[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,110,0,25,[9,45,67,89,109,140,219,245,268,289,321,345,368,396,428,450,469,505,531,554,579,599,618,638,679],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":44},"100628287","phase-2-herizon-breast-a-ctdna-guided-adaptive-study-of-sequential-anti-her2-therapies-and-cns-prophylaxis-to-induce-long-term-remission-100628287",false,"NCT07459673","HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission","Inclusion Criteria:\n\n* Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.\n* Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.\n* HER2 IHC results of 3+.\n* Life expectancy of ≥12 weeks.\n* Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy.\n* Must have measurable disease per PERCIST 1.0.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study intervention.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 3 during the intervention period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  * A WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) within 72 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n  * Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of therapy.\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Criteria for known Hepatitis B and C positive subjects: Hepatitis B and C screening tests are required as per MSK policy but do not need to be repeated prior to study unless there is a known history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n* Participants who have active hepatitis B infection (defined as HBsAg positive and\u002For detectable HBV DNA) are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Participants should remain on anti-viral therapy throughout study intervention and follow MSK guidelines for HBV anti-viral therapy post completion of study intervention.\n* Participants with a history of HCV infection (defined as anti-HCV Ab positive and detectable HCV RNA) are eligible if HCV viral load is undetectable at screening.\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nTable 1 Adequate Organ Function Laboratory Values Hematological Absolute neutrophil count (ANC): ≥1500\u002FµL Platelets: ≥100 000\u002FµL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\nRenal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × ULN\n\nHepatic Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT)\n\nCoagulation\n\nInternational normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT):\n\n≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\nExclusion Criteria:\n\n* Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH\n* Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses \\>10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded.\n* Has known CNS metastases and\u002For leptomeningeal carcinomatosis.\n* Has a history or evidence of active pneumonitis or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has grade \\>=3 neuropathy of any etiology.\n* Has an active infection requiring antibiotics.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has an inability to swallow capsules or tablets.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has significant cardiovascular impairment within 12 months of the first dose of study drug: such as NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n* Has a left ventricular ejection fraction (LVEF) below the institutional normal range of 50%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Known intolerance to any of the study drugs (or any of the excipients).\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.",[26,27,28],"Breast Cancer","HER2-positive Breast Cancer","Breast Cancer Stage IV",[30,27,28,31,32],"breast cancer","Memorial Sloan Kettering Cancer Center","25-258","RECRUITING","2026-08-19",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":37},"2026-03-04",{"date":41,"type":20},"2030-03-04",{"name":31,"class":43},"OTHER",7,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100550040","phase-2-bre-10-biomarker-optimization-of-neoadjuvant-therapy-in-breast-cancer-100550040","NCT06441890","BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer","BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial","BRE-10","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* ECOG performance status 0, 1, or 2\n* Histologically confirmed invasive breast cancer documented by core needle or surgical biopsy with 90 days prior to study registration.\n* HER2-positive by IHC or FISH according to ASCO\u002FCAP 2018 guidelines\n* HER2-enriched subtype on the MammaPrint\u002FBluePrint gene expression profile within 90 days prior to study registration.\n* Curative resection of primary breast tumor(s) is planned; ipsilateral axillary nodes will be sampled by sentinel lymph node biopsy or axillary dissection\n* Treating Oncologist recommends neoadjuvant chemotherapy\n* No evidence of distant metastatic disease\n* AJCC clinical stage: cT1c-T3, cN0-N2\n* Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.\n\nAdequate organ function as defined below:\n\nLeukocytes ≥2,000\u002Fmm3 Platelet count ≥ 75,000\u002Fmm3 Absolute Neutrophil Count (ANC) ≥ 1,000\u002Fmm3 Hemoglobin (Hgb) ≥ 9.0 g\u002FdL Creatinine\u002FCalculated Creatine clearance (CrCI) Cr \\\u003C 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \\> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n\n* Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the assigned treatment regimen is appropriate therapy for all primary tumors requiring chemotherapy.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. or the Legally Authorized Representative (LAR) is able to provide consent and HIPAA authorization.\n* Women of childbearing potential must agree to use a barrier form of contraception if they are sexually active with a male partner and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n* Patients with history of HIV\u002FAIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the protocol treatment regimen and the following criteria is met:\n\n  \\- Patients without a history of AIDS-defining opportunistic infections within the past 12 months.\n* Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria.\n* Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment\n\nExclusion Criteria\n\n* Any prior therapy for this breast cancer\n* Active infection requiring systemic therapy at the time of study registration\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity (e.g., compromised liver function, major cardiovascular or cerebrovascular event within the past 6 months, uncontrolled diabetes mellitus or hypertension), as determined by treating physician.\n* Any contraindication for any chemotherapy drug used in the assigned regimen.\n* Baseline sensory neuropathy \\> grade 1\n* History of hypersensitivity to any of the drugs in the treatment regimen. Patients with history of hypersensitivity may be treated on this protocol with either nab-paclitaxel or docetaxel.\n* Prisoners",{"count":54,"type":20},28,[23],"Adult men and women with early-stage, IHC\u002FFISH-defined HER2-positive breast cancer will have a MammaPrint®\u002FBluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care",[26,27],{"date":59,"type":37},"2026-08-21",{"date":61,"type":37},"2024-12-05",{"date":63,"type":20},"2028-06",{"name":65,"class":43},"University of Illinois at Chicago",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100431055","phase-2-atempt-20-adjuvant-t-dm1-vs-th-100431055","NCT04893109","ATEMPT 2.0: Adjuvant T-DM1 vs TH","A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)","Inclusion Criteria:\n\n* Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.\n\n  * If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\\&E or immunohistochemistry (IHC) will be considered node-negative.\n  * Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.\n  * Patients who have an area of a T1aN0, ER+ (defined as \\>10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.\n* HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status.\n\nNOTE: DCIS components will not be counted in the determination of HER2 status\n\n* ER\u002FPR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol.\n* Bilateral breast cancers that individually meet eligibility criteria are allowed.\n* Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics).\n* Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible.\n* ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer\n* ≥ 18 years of age with any menopausal status.\n* ECOG Performance Status 0 or 1\n* All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection\n\n  * All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.\n* Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. Radiation to the conserved breast is required.\n* Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer. Patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks.\n* Prior oophorectomy for cancer prevention is allowed.\n* Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy. Patients who have undergone whole breast radiation are not eligible.\n* Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation.\n* Adequate bone marrow function:\n\n  * ANC ≥ 1000\u002Fmm3,\n  * Hemoglobin ≥ 9 g\u002Fdl\n  * Platelets ≥ 100,000\u002Fmm3\n* Adequate hepatic function:\n\n  * Total bilirubin ≤ 1.2mg\u002FdL\n  * AST and ALT ≤ 1.5x Institutional ULN\n  * For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN.\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.\n* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and\u002For partner. Contraceptive use must be continued for the duration of the study treatment and for 7 months after the last dose of study treatment. Hormonal birth control methods are not permitted.\n* Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides, which must be sent to DFCI for correlative research. If a tissue block is unavailable, sites may send one H\\&E-stained slide and 15 unstained sections of paraffin-embedded tissue on uncharged slides. Slide sections should be 4-5 microns in thickness. It is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 mm diameter coring tool. If tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue.\n* Willing and able to sign informed consent\n* Must be able to read and understand English in order to participate in the quality of life surveys. If patient does not read and understand English, the patient is still eligible, but cannot participate in the quality of life surveys.\n\nExclusion Criteria:\n\n* Any of the following due to teratogenic potential of the study drugs:\n\n  * Pregnant women\n  * Nursing women\n  * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).\n  * Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).\n* Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations\u002Fnodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)\n* Patients with a history of previous invasive breast cancer.\n* History of prior chemotherapy in the past 5 years.\n* History of paclitaxel therapy\n* Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.\n* Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.",{"count":75,"type":20},500,[23],"This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.\n\nThe name of the study drugs involved are:\n\n* Trastuzumab-emtansine (T-DM1, Kadcyla)\n* Trastuzumab SC (Herceptin Hylecta)\n* Paclitaxel",[26,27],[26,27],"2026-08-17",{"date":34,"type":37},{"date":83,"type":37},"2021-06-16",{"date":85,"type":20},"2029-05-01",{"name":87,"class":43},"Dana-Farber Cancer Institute",53,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":66},"100388039","phase-1-monitoring-her2-breast-cancer-neoadjuvant-treatment-with-advanced-petmri-100388039","NCT04332588","Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET\u002FMRI","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old and ≤ 75 years old\n2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and\u002For positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility\n3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment\n4. Estimated life expectancy of greater than one year\n5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent F\n2. Weight over 350 lbs., due to the scanner bore size\n3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.\n4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)\n5. Unable to lie still on the imaging table for one (1) hour\n6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)","FEMALE",{"count":7,"type":20},[98],"PHASE1","The purpose of the study is to see if using an investigational drug called \\[18F\\]FMISO with PET\u002FMRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.",[27],"2026-08-13",{"date":80,"type":37},{"date":104,"type":37},"2022-03-25",{"date":106,"type":20},"2027-08",{"name":108,"class":43},"University of Alabama at Birmingham",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":128,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100652042","phase-4-tucatinib-continuation-study-100652042","NCT07768358","Tucatinib Continuation Study","TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES","Inclusion Criteria:\n\n1. Be receiving tucatinib as a study intervention and deriving clinical benefit without evidence of disease progression (as determined by the investigator) in a tucatinib Parent Study.\n2. Agree to follow the reproductive criteria.\n3. Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.\n4. Be capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.\n2. Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).\n3. Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.",{"count":117,"type":20},175,[119],"PHASE4","The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment. These participants were part of Pfizer-sponsored tucatinib parent studies that will be closed. Additional follow-up safety information will be collected. This will allow further understanding of the safety profile of tucatinib in participants who continue to receive the study treatment.",[27,122,123,124,125,126,127],"Cervical Cancer","Biliary Tract Neoplasms","Urothelial Cancer","Advanced Non-Small Cell Lung Cancer","Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)","Colorectal Cancer",[129],"tucatinib","NOT_YET_RECRUITING","2026-08-12",{"date":80,"type":37},{"date":134,"type":20},"2026-08-24",{"date":136,"type":20},"2032-03-13",{"name":138,"class":139},"Pfizer","INDUSTRY",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":149,"type":20},300,[98,23],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[153,154,155,156,157,158,159,160,127,26,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,27,178,179],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-08-07",{"date":211,"type":37},"2026-08-10",{"date":213,"type":37},"2020-10-29",{"date":215,"type":20},"2027-12-31",{"name":217,"class":139},"PMV Pharmaceuticals, Inc",77,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":235,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":66},"100549871","phase-2-the-sappho-study-sequential-therapy-with-curative-intent-in-de-novo-her2-metastatic-breast-cancer-100549871","NCT06439693","The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer","A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study","Inclusion criteria:\n\n* Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging.\n* Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll.\n* No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab\u002Fpertuzumab\u002Ftaxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry.\n* Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:\n\n  * Hgb ≥9.0 g\u002FdL\n  * Absolute Neutrophil Count ≥ 1,000 \u002Fmm3\n  * Platelets ≥100,000\u002Fmm3\n  * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\\'s syndrome.\n  * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases\n  * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL\u002Fmin\n* Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:\n\n  * CD4+ T-cell (CD4+) counts \\> 350 cells\u002FuL\n  * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments\n  * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.\n* Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies:\n\n  * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n  * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.\n  * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:\n\n  * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.\n  * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is:\n\n    * 7 days for stereotactic radiosurgery (SRS);\n    * 14 days for whole-brain radiation therapy (WBRT);\n    * 28 days for surgical resection.\n  * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible (i.e., adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer).\n* This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her Partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study therapy.\n* Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year.\n* Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n* Prior history of invasive breast carcinoma\n* Treatment with any other investigational agents for this condition.\n* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.\n* Extracranial palliative radiotherapy within 7 days prior to enrollment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.\n* Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).\n* Subjects must not have any of the following:\n\n  * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent).\n  * Known or concurrent leptomeningeal disease on screening MRI\n  * Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* History of other lung disease, such as:\n\n  * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  * Prior pneumonectomy.\n* Active or uncontrolled clinically serious infection\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have ongoing ≥ Grade 2 diarrhea of any etiology\n* Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and\u002For CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.\n* Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment.",{"count":227,"type":20},72,[23],"The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.\n\nThe names of the study drugs involved in this study are:\n\n* Paclitaxel (a type of anti-microtubule agent)\n* Docetaxel (a type of anti-microtubule agent)\n* Nab-Paclitaxel (a type of anti-microtubule agent)\n* Trastuzumab (a type of IgG1 kappa monoclonal antibody)\n* Pertuzumab (a type of monoclonal antibody)\n* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)\n* Tucatinib (Tyrosine Kinase HER2 Inhibitor)\n* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)",[231,26,232,233,27,234],"Breast Cancer Female","Breast Cancer Metastatic","Estrogen Receptor-positive Breast Cancer","Stage IV Breast Cancer",[26,231,232,236,27,234],"Estrogen Receptor-Positive Breast Cancer","2026-08-04",{"date":239,"type":37},"2026-08-06",{"date":241,"type":37},"2024-08-08",{"date":243,"type":20},"2033-03-30",{"name":87,"class":43},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":4},"100650469","phase-3-de-escalation-neoadjuvant-therapy-for-intermediate-risk-her2-positive-early-breast-100650469","NCT07748260","De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast","De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast:a Randomised,Open-label,Multicentre,Phase 3 Trial","neoDIRHP","Inclusion Criteria:\n\nHistopathologically confirmed HER2-positive invasive breast cancer; Clinical staging of disease classified as T2N0M0.\n\nExclusion Criteria:\n\nPatients who have undergone chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this condition; Due to severe and uncontrolled medical conditions, the investigator deems chemotherapy contraindicated.",{"count":254,"type":20},592,[256],"PHASE3","High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients. Total pCR rates in breast and axilla have been described as high as 64%, and with an even higher rate of \\>80% in patients with HER2-positive and hormone receptor (HR) negative tumors.\n\npCR is associated with better long-term outcomes in patients with HER2-positive breast cancer. Neoadjuvant treatment of HER2-positive breast cancer typically consists of six cycles of treatment. Longer duration of treatment is associated with higher pCR-rates but also with increased toxicity. It is therefore important to investigate which patients can safely be treated with less than six cycles of chemotherapy and which patients require six cycles for maximum efficacy.It is hypothesized that patients with a complete pathologic response may not benefit from additional chemotherapy, while those with residual invasive disease require further treatment. This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.",[27],"2026-08-03",{"date":261,"type":37},"2026-08-05",{"date":263,"type":20},"2026-09-01",{"date":265,"type":20},"2031-07-01",{"name":267,"class":43},"Guangdong Provincial People's Hospital",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100624769","phase-2-ro7771950-versus-tucatinib-in-combination-with-trastuzumab-and-capecitabine-in-people-with-locally-advanced-or-metastatic-breast-cancer-that-is-human-epidermal-growth-factor-receptor-2-her2-positive-100624769","NCT07413939","RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive","A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II\u002FIII Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases","BREnnA","Inclusion Criteria:\n\n* Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.\n* Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.\n* Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.\n* At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.\n* Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication.\n* Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is \\> 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI\u002FMBC is not permitted.\n* Has protocol-defined adequate organ and bone marrow function.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Baseline left ventricular ejection fraction (LVEF) ≥ 50%.\n\nExclusion Criteria:\n\n* Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.\n* Known active\u002Funtreated hepatitis B or C or chronic liver disease.\n* Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events\u002Finterventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.\n* Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.\n* Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.",{"count":277,"type":20},650,[23,256],"The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.",[27],{"date":261,"type":37},{"date":283,"type":37},"2026-05-21",{"date":285,"type":20},"2032-09-29",{"name":287,"class":139},"Hoffmann-La Roche",152,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":302,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"100648669","phase-2-smp-656-for-her2-positive-advanced-breast-cancer-100648669","NCT07726342","SMP-656 for HER2-Positive Advanced Breast Cancer","A Randomized, Open-Label, Dose-Optimization Phase II Clinical Trial to Evaluate the Efficacy and Safety of Single-Agent SMP-656 in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Progressed After Prior Treatment With HER2-Targeted Topoisomerase Inhibitor ADCs","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical trial, understand and comply with study procedures, and provide written informed consent voluntarily;\n2. Female patients aged ≥ 18 years at the time of signing the informed consent form;\n3. Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of hormone receptor (HR) status;\n4. HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ with positive fluorescence in situ hybridization (FISH+) results;\n5. Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior treatment with one TOP inhibitor ADC targeting HER2 (e.g., DS-8201 and other ADCs with topoisomerase inhibitor payloads), and have experienced disease progression after no more than three lines of standard therapy for recurrent or metastatic disease; 1) Endocrine monotherapy is excluded from the abovementioned standard therapy lines; 2) Disease recurrence occurring within 12 months following neoadjuvant or adjuvant chemotherapy will be regarded as progression after first-line standard therapy;\n6. Have at least one measurable target lesion per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ;\n7. ECOG performance status 0-1;\n8. Expected survival ≥ 3 months;\n9. Bone marrow, hepatic, renal and coagulation function shall be deemed adequate based on laboratory tests performed within 7 days prior to the first dose of the investigational product. Blood transfusion or growth factor supportive therapy is prohibited within 14 days before the first administration of the investigational product：\n\n   * Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 80 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL;\n   * Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total serum bilirubin (TBIL) ≤ 1.5 × ULN, with the following exceptions;\n   * For participants with confirmed liver metastases: AST and\u002For ALT ≤ 5 × ULN;\n   * For participants diagnosed with Gilbert's syndrome: TBIL ≤ 3 × ULN;\n   * Serum albumin ≥ 30 g\u002FL;\n   * Renal function: Creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (calculated via the Cockcroft-Gault formula), OR serum creatinine ≤ 1.5 × ULN;\n   * Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Women of childbearing potential (WOCBP) must agree to use highly effective contraception or maintain abstinence from the time of informed consent signature through 6 months after the last administration of the investigational product；For WOCBP, serum pregnancy testing performed within 7 days prior to the first dose of the investigational product must yield a negative result.\n\nExclusion Criteria:\n\n1. Patients with inflammatory breast cancer;\n2. Have received eribulin in prior lines of therapy;\n3. Have received prior treatment with ADCs carrying tubulin inhibitor payloads for recurrent or metastatic disease;\n4. Prior anti-tumor therapy consisting of utidelone or vinca alkaloids as the last regimen;\n5. Patients with a known history of severe hypersensitivity to inetetamab, SMP-656, or any of their excipients;\n6. Patients with meningeal metastases;\n7. Patients with active central nervous system (CNS) metastases are excluded, with the following exception: symptomatic CNS metastases limited to supratentorial region and\u002For cerebellum (i.e., no midbrain, pons, medulla oblongata or spinal cord metastases) that have received local therapy, with neurological symptoms stabilized for at least 2 weeks prior to the first dose of investigational product, and no requirement for steroid therapy or receiving prednisone ≤10 mg\u002Fday (or equivalent corticosteroids) ;\n8. Patients diagnosed with any other malignancy (other than the study tumor type) within 5 years prior to the first dose of the investigational product, except curatively treated localized malignancies such as basal cell carcinoma of the skin;\n9. Previous, current or suspected interstitial lung disease (ILD), drug-induced interstitial lung disease; or clinically significant active pneumonia identified at screening; or radiation pneumonitis, or other severe pulmonary disorders impairing respiratory function, which in the Investigator's judgment may interfere with the detection or management of investigational product-related pulmonary toxicity;\n10. Patients with a clinically significant history of cardiovascular disease, including but not limited to： (1) Left ventricular ejection fraction (LVEF) \\\u003C 50%; congestive heart failure with New York Heart Association (NYHA) functional class \\> 2; (2) Have experienced myocardial infarction, unstable angina, severe pericardial disease or severe myocardial disease within the previous 6 months; (3) Presence of cardiac valve regurgitation or stenosis requiring therapeutic intervention; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention; poorly controlled malignant arrhythmias despite medication; complete left bundle branch block, second-degree or third-degree atrioventricular block; (5) QTc interval \\> 470 ms at screening (for female participants), or known family history of long QT syndrome; (6) Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy) ;\n11. History of arterial or venous thromboembolic events within 6 months prior to the first dose of the investigational product, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;\n12. Participants with uncontrollable pleural effusion, pericardial effusion or ascites as judged by the Investigator, which requires repeated drainage once every two weeks or more frequently. Participants with indwelling pleural catheters are permitted to enroll;\n13. Have received live attenuated vaccines within 4 weeks prior to the first dose of the investigational produc, or plan to receive live attenuated vaccines during the study;\n14. Patients with severe infection within 4 weeks prior to the first dose of the investigational product, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infection with CTCAE Grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose (prophylactic antibiotics excluded) ;\n15. Patients meeting any of the following criteria will be excluded: patients with active hepatitis B or hepatitis C；For patients positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), enrollment is permitted only if quantitative hepatitis B virus DNA (HBV-DNA) is below the upper limit of normal (ULN) of the study site laboratory；For patients positive for hepatitis C antibody (HCV-Ab), enrollment is permitted only if HCV RNA is below the ULN of the study site laboratory；Positive human immunodeficiency virus (HIV) antibody test; active syphilis infection; active tuberculosis infection;\n16. Patients with unresolved prior anti-tumor treatment-related toxicities (alopecia excluded) remaining at Grade \\>1 or not recovered to baseline, except adverse events (AEs) deemed not to pose a safety risk by the Investigator;\n17. Patients with Grade ≥2 peripheral neuropathy; or prior history of Grade ≥3 neurotoxicity \u002F peripheral neuropathy; or permanent discontinuation of previous anti-tumor treatment due to neurotoxicity or peripheral neuropathy;\n18. Patients with a history of allogeneic stem cell transplantation or solid organ transplantation, or those planning to receive allogeneic stem cell transplantation or solid organ transplantation during the study;\n19. Patients who have participated in any other clinical trial within 4 weeks or 5 half-lives prior to the first dose of the investigational product, whichever is shorter;\n20. Patients who received radiotherapy within 4 weeks prior to the first dose of the investigational product are excluded, except palliative radiotherapy administered for symptom control within 2 weeks before the first dose of investigational product;\n21. Patients who received systemic anti-tumor therapy within 4 weeks prior to the first dose of the investigational product are excluded, except for the following： 1) Enrollment is permitted only if at least 6 weeks have elapsed between the completion of prior nitrosourea or mitomycin chemotherapy and the first dose of the investigational product; 2) Enrollment is allowed only if a minimum of 1 week has passed between the discontinuation of prior small-molecule targeted therapy and the first dose of the investigational product; 3) Enrollment is permitted only if a minimum of 2 weeks have elapsed between discontinuation of prior traditional Chinese medicine with anti-tumor effects and the first dose of the investigational product;\n22. articipants who have undergone major surgery within 4 weeks prior to the first dose of the investigational product, or are expected to receive major surgery during the study period (diagnostic surgery excluded); those who received diagnostic or minimally invasive surgery within 1 week before the first dose are also excluded;\n23. Patients requiring long-term treatment with corticosteroids or immunosuppressive agents (e.g., active autoimmune diseases requiring systemic therapy). Replacement therapies such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency are permitted;\n24. Prior documented history of neurological or psychiatric disorders, including epilepsy or dementia;\n25. Female Patients who are pregnant, breastfeeding, or planning to become pregnant during the study;\n26. Patients with severe concomitant diseases that may compromise patient safety or interfere with study completion as judged by the Investigator (e.g., severe hypertension, diabetes mellitus, thyroid disorders), or any other conditions deemed inappropriate for study participation by the Investigator .",{"count":19,"type":20},[23],"The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are:\n\nWhat is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks.\n\nParticipants will:\n\nComplete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies",[27,300,301],"Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)",[303,304,305,306,307,308,309,310,300],"SMP-656","Randomized Open-Label Trial","HER2","Antibody-Drug Conjugate","Trastuzumab Deruxtecan resistant","Phase II Trial","Dose Optimization","Topoisomerase Inhibitor","2026-07-22",{"date":313,"type":37},"2026-07-24",{"date":315,"type":20},"2026-07-16",{"date":317,"type":20},"2027-10-20",{"name":319,"class":139},"Chengdu SciMount Pharmatech Co., Ltd.",15,{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":21,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100648157","phase-2-fulvestaciclib-combined-with-anti-her2-and-endocrine-therapy-for-hrher2-advanced-breast-cancer-100648157","NCT07716046","Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+\u002FHER2+ Advanced Breast Cancer","Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+\u002FHER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study","FACET","Inclusion Criteria:\n\n* Age ≥ 18 years, with inoperable locally advanced or recurrent\u002Fmetastatic breast cancer not amenable to curative-intent therapy.\n* Histologically or cytologically confirmed hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. HR+ is defined as estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity with ≥1% of invasive tumor cells positive by immunohistochemistry (IHC). HER2+ is defined as IHC 3+ or IHC 2+ with in situ hybridization (ISH) positivity.\n* No prior systemic therapy for advanced breast cancer, including endocrine therapy, chemotherapy, anti-HER2 therapy, or any CDK4\u002F6 inhibitor.\n* Patients may have received neoadjuvant or adjuvant therapy. If prior endocrine therapy was received in the neoadjuvant\u002Fadjuvant setting, the disease-free interval from completion of endocrine therapy to randomization must be ≥12 months. If prior anti-HER2 therapy was received, the disease-free interval from completion of anti-HER2 therapy to randomization must be ≥6 months.\n* Patients with stable central nervous system (CNS) metastases (meeting all the following criteria: no disease progression on screening imaging after local therapy; at least 3 weeks from completion of local CNS therapy to Cycle 1 Day 1; no requirement for medication to control symptoms) or asymptomatic CNS metastases are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Any menopausal status. Postmenopausal status is defined as: a. bilateral oophorectomy; b. age ≥60 years; c. age \\\u003C60 years with amenorrhea for \\>1 year in the absence of chemotherapy, tamoxifen, toremifene, or ovarian function suppression, and with serum FSH and estradiol levels within the postmenopausal range. For patients \\\u003C60 years on tamoxifen or toremifene with amenorrhea, serum FSH and estradiol levels must be within the postmenopausal range on consecutive measurements.\n* At least one evaluable lesion per RECIST 1.1 (measurable and\u002For non-measurable lesion).\n* For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to randomization, and agreement to use adequate contraception during study treatment and for 6 months after the last dose of fulvestaciclib.\n* Voluntarily sign the informed consent form (ICF), understand the study, and be willing to comply with all study procedures and follow-up.\n* Adequate bone marrow and organ function defined as:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Hemoglobin ≥90 g\u002FL (no red blood cell transfusion within 14 days prior to randomization); Platelet count ≥75 × 10⁹\u002FL; Serum total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN (or ≤5 × ULN in the presence of liver metastases); Serum creatinine ≤1 × ULN or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula); Baseline left ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer.\n* Leptomeningeal disease.\n* Active brain metastases (patients with asymptomatic brain metastases, or clinically stable and not requiring steroids or other CNS-directed therapy for ≥4 weeks are eligible).\n* Diagnosis of any other malignancy, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that has been definitively treated.\n* Known severe hypersensitivity to any component of the study drugs.\n* Myocardial infarction within 6 months prior to first dose; uncontrolled cardiac arrhythmias (QTc interval ≥470 ms by Fridericia's formula); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; LVEF \\\u003C50% on echocardiography; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention.\n* Dysphagia, active gastrointestinal disease, major gastrointestinal surgery, malabsorption syndrome, or any other condition that may interfere with the absorption of study drugs.\n* Known active infection, including hepatitis B (HBsAg positive with HBV DNA ≥1×10⁴ copies\u002FmL or ≥2000 IU\u002FmL), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.\n* Major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody therapy, or other systemic antitumor therapy within 30 days prior to the first dose, or any therapy that the investigator considers may interfere with the efficacy of study drugs.\n* Concurrent use of other investigational drugs or therapies.\n* Planned or prior organ or bone marrow transplantation.\n* Known history of substance abuse or drug addiction.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":330,"type":20},240,[23],"This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4\u002F6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).\n\nPatients with HR+\u002FHER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).\n\nArm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.\n\nArm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.\n\nArm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).\n\nFor premenopausal\u002Fperimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.\n\nThe primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).",[26,27,334,335],"Hormone Receptor-positive Breast Cancer","HR+\u002FHER2+ Breast Cancer","2026-07-20",{"date":338,"type":37},"2026-07-21",{"date":340,"type":20},"2026-10-01",{"date":342,"type":20},"2032-12-31",{"name":344,"class":43},"Fudan University",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":66},"100550687","phase-2-decreasing-treatment-for-metastatic-her2-positive-breast-cancer-with-undectable-cancer-levels-in-blood-tests-100550687","NCT06450314","Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.","De-escalation of Medical Therapies in HER2-positive Metastatic Breast Cancer in Long-term Persistent Response and Minimal Residual Disease Undetectable in Circulating Tumor DNA","HEROES","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;\n2. Men or women ≥18 years of age;\n3. Documented diagnosis of locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer (HER2-positive is defined as HER2 3+ immunohistochemical overexpression, or the presence of HER2 amplification, according to ASCO-CAP guidelines);\n4. Must have an adequate archival tumor tissue sample available for next-generation sequencing (NGS) analysis by central laboratory, in order to design the ctDNA test (based on most recent available tumor tissue sample, metastatic biopsy (bone tissue excluded) and primary tumor authorised);\n5. Patient with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) ≤1;\n6. Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab\u002FPertuzumab, Trastuzumab-Deruxtecan or T-DM1) treatment for at least 2 years in any line setting, for their locally advanced inoperable or metastatic HER2 + breast cancer (prior treatment interruption of 3 months maximum is allowed), with complete response or partial response at last radiological assessment;\n\n   Note: the number of patients who received anti-HER2 targeted therapy in second line setting or more will be capped to 50% of the overall population\n7. In case of bone disease only, complete metabolic response in 18-FDG pet-scanner is required;\n8. Patient with treated (surgery and\u002For radiation therapy) and controlled primary tumor;\n9. Patients with ER-positive disease may or may not have received concomitant endocrine therapy (which must be continued if present). Concomitant ovarian blockade using Luteinizing Hormone-Releasing Hormone (LHRH) agonists is authorised as well;\n10. Adequate cardiac, renal, haematological and hepatic functions according to guidelines hospital;\n11. Women of childbearing potential must have a negative serum or urine pregnancy test done within 28 days before inclusion;\n12. Non post-menopausal women and fertile men must agree to use adequate contraception methods during the study. Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive;\n13. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan and other study procedures including follow-up;\n14. Patients must be affiliated to a Social Security System (or equivalent).\n\nExclusion Criteria:\n\n1. Any breast cancer progression over the past 2 years or at study entry;\n2. Patient concurrently using other approved or investigational antineoplastic agents than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, TDM-1 +\u002F- endocrine therapy;\n3. Had an history of tumoral meningitis or clinically active central nervous system metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;\n\n   1. Subjects with curatively treated brain metastases (i.e., complete removal surgery or stereotactic radiotherapy) who are no longer symptomatic and do not require treatment with corticosteroids or anticonvulsants may be included in the study provided they have recovered from the acute toxicity of radiotherapy and there has been no progression of the brain metastases within the past 24 months.\n   2. Subjects with brain metastases only or treated with whole brain radiotherapy will be excluded of the study\n4. Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;\n5. History of any prior ipsi or contralateral breast cancer (except in case of DCIS) unless if both primary tumors were confirmed to be HER2-positive;\n6. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease and treatment for at least 3 years;\n7. Major surgery within 2 weeks prior to study entry;\n8. Pregnant women or women who are breast-feeding;\n9. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;\n10. Participation in another clinical study whose procedures interfere with those of the study (within 28 days prior to patient enrolment and for the duration of the study);\n11. Persons deprived of their liberty or under protective custody or guardianship.",{"count":354,"type":20},170,[23],"Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing.\n\nThe main question it aims to answer is :\n\n• Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?",[300,27],[359,360],"de-escalation","ctDNA test",{"date":338,"type":37},{"date":363,"type":37},"2025-01-25",{"date":365,"type":20},"2029-12-15",{"name":367,"class":43},"UNICANCER",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100600814","phase-2-a-phase-2-neoadjuvant-study-of-zanidatamab-in-combination-with-chemotherapy-in-participants-with-her2-positive-breast-cancer-100600814","NCT07102381","A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","EmpowHER 208","Inclusion Criteria:\n\n1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.\n2. Has histologically confirmed HER2-positive breast cancer\n3. Has a known hormone receptor (HR) status of the primary tumor\n4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.\n5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate organ function\n8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.\n9. Adequate contraceptive precautions\n10. Participants with known HIV are eligible unless:\n\n    1. CD4+ T Cell count is less than or equal to 350 microliters (uL)\n    2. Detectable viral load, or\n    3. Receiving protease inhibitors or cobicistat\n\nExclusion Criteria:\n\n1. Has Stage IV (metastatic) breast cancer.\n2. Has bilateral breast cancer.\n3. Has a history of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.\n4. Has uncontrolled hypertension\n5. Has significant symptoms from peripheral neuropathy\n6. Has an active uncontrolled infection\n7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.\n8. Known active hepatitis B or C infection.\n9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.\n10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer\n11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol\n12. Receipt of a live vaccine within 4 weeks prior to enrollment\n13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy",{"count":377,"type":20},125,[23],"The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer",[27,26],[382,383,384,385],"HER2-positive early breast cancer","invasive breast carcinoma","zanidatamab","breast neoplasm","2026-07-14",{"date":388,"type":37},"2026-07-15",{"date":390,"type":37},"2025-09-24",{"date":392,"type":20},"2030-08-01",{"name":394,"class":139},"Jazz Pharmaceuticals",33,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":21,"phases":406,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":66},"100647489","phase-1-entinostat-plus-pyrotinib-and-endocrine-therapy-in-advanced-triple-positive-breast-cancer-after-trastuzumab-failure-100647489","NCT07708194","Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure","An Open-Label, Single-Center, Exploratory Phase Ib\u002FII Clinical Study of Entinostat Combined With Pyrotinib Plus Endocrine Therapy in Patients With Advanced Triple-Positive Breast Cancer After Trastuzumab Failure","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years, female, premenopausal or postmenopausal.\n2. Histologically confirmed HR+\u002FHER2+ breast cancer (HER2 positive defined as IHC 3+ or FISH confirmed by the pathology department of the study center).\n3. Histologically confirmed locally advanced breast cancer (not amenable to curative local therapy) or recurrent\u002Fmetastatic breast cancer.\n4. Prior treatment with trastuzumab and taxane-based anticancer therapy.\n5. Received 1-2 prior lines of systemic anticancer therapy in the advanced setting.\n6. Life expectancy ≥ 3 months.\n7. At least one measurable lesion per RECIST v1.1.\n8. ECOG performance status 0-2.\n9. All acute toxicities from prior anticancer therapy resolved to Grade 0-1 (per NCI CTCAE v5.0), except alopecia and toxicities deemed by the investigator to pose no safety risk.\n10. Adequate bone marrow function: ANC ≥ 1.5×10\\^9\u002FL, platelet ≥ 100×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL.\n11. Adequate hepatic and renal function: TBIL ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN (or ≤ 5×ULN in the presence of liver metastases); BUN and Cr ≤ 1.5×ULN with creatinine clearance ≥ 50 mL\u002Fmin.\n12. Voluntarily participate and sign written informed consent. -\n\nExclusion Criteria:\n\n1. Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.\n2. Prior treatment with any HDAC inhibitor for antitumor therapy.\n3. Prior or current use of any HER2-targeted tyrosine kinase inhibitor (including lapatinib, neratinib, pyrotinib, etc.).\n4. Known allergy to any component of the study drugs.\n5. Other malignancy within 5 years prior to enrollment, except cured papillary thyroid carcinoma, cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n6. Participation in another drug clinical trial within 4 weeks prior to enrollment.\n7. History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n8. Uncontrolled significant cardiovascular disease: clinically significant QTc interval prolongation or QTc \\> 450 ms at screening; severe cardiac impairment (NYHA \\> Class II); unstable angina or myocardial infarction within 6 months; or severe arrhythmia.\n9. Pregnant or lactating women, or positive pregnancy test at baseline; or women of childbearing potential who are unwilling to use effective contraception during the study and for at least 8 weeks after the last dose.\n10. Concomitant diseases that, in the investigator's judgment, could seriously endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disease, active infection).\n11. Known history of neurological or psychiatric disorders, including epilepsy or dementia.\n12. Active hepatitis (HBV: HBsAg positive with HBV DNA ≥ 500 IU\u002FmL; HCV: HCV antibody positive with HCV RNA \\> ULN).\n13. Any condition that, in the investigator's judgment, makes the patient unsuitable for study participation.\n\n    \\-","75 Years",{"count":405,"type":20},94,[98,23],"This is an open-label, single-center, exploratory, Phase Ib\u002FII clinical trial evaluating the safety and efficacy of entinostat combined with pyrotinib and endocrine therapy in patients with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have failed prior trastuzumab-based therapy.\n\nThe study consists of two parts: Part I (Phase Ib) employs a 3+3 dose-escalation design to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of entinostat when given in combination with pyrotinib (400 mg daily) and endocrine therapy. Part II (Phase II) uses a Simon two-stage design to further evaluate the efficacy and safety of the combination at the RP2D. The primary efficacy endpoint is progression-free survival (PFS) based on RECIST v1.1. A total of approximately 79-94 participants will be enrolled.",[26,27,409,300],"Hormone Receptor-Positive Breast Cancer",[411,412,413,414,415,416,417,418,419],"Entinostat","Pyrotinib","HDAC Inhibitor","HER2-positive","Hormone Receptor-positive","Endocrine Therapy","Trastuzumab Resistance","Triple-positive Breast Cancer","Epigenetic Therapy","2026-07-12",{"date":315,"type":37},{"date":423,"type":37},"2025-06-23",{"date":425,"type":20},"2027-02",{"name":427,"class":43},"Tianjin Medical University Cancer Institute and Hospital",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":403,"enrollmentInfo":435,"targetDuration":4,"studyType":21,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"100644772","phase-3-a-trial-comparing-gq1005-and-t-dm1-in-patients-with-her2-positive-unresectable-or-metastatic-breast-cancer-100644772","NCT07673029","A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane","Inclusion Criteria:\n\n* Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.\n* Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.\n* Presence of at least one measurable lesion according to RECIST v1.1\n* Expected survival time ≥ 12 weeks.\n* Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.\n\nExclusion Criteria:\n\n* Prior anti-HER2 ADC therapy.\n* Previous history of interstitial lung disease\u002Fnoninfectious pneumonitis\u002Fradiation pneumonitis requiring steroid therapy.\n* Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.\n* Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer\n* Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult\n* Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.",{"count":436,"type":20},228,[256],"This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and\u002For metastatic breast cancer patients previously treated with trastuzumab and taxane.",[27],"2026-06-24",{"date":442,"type":37},"2026-06-29",{"date":444,"type":37},"2025-01-10",{"date":446,"type":20},"2028-01-09",{"name":448,"class":139},"GeneQuantum Healthcare (Suzhou) Co., Ltd.",70,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":21,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":467,"locationsCount":66},"100609700","phase-1-neoadjuvant-complete-response-customized-treatment-approach-for-definitive-management-of-breast-cancer-100609700","NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases",{"count":458,"type":20},84,[98,23],"This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[26,27,172],"2026-06-20",{"date":440,"type":37},{"date":465,"type":20},"2026-09-15",{"date":215,"type":20},{"name":468,"class":43},"Ohio State University Comprehensive Cancer Center",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":21,"phases":478,"briefSummary":479,"conditions":480,"keywords":493,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":477,"type":20},134,[23],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[481,482,483,157,26,27,127,484,485,486,487,488,489,490,491,492],"Brain Cancer","Brain Metastases","Melanoma","Gastrointestinal Cancer","SRS","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[481,482,483,157,26,27,127,484,485,486,494,488,489,490,491,492],"Whole brain radiation","2026-06-16",{"date":497,"type":37},"2026-06-17",{"date":499,"type":37},"2021-09-15",{"date":501,"type":20},"2029-05",{"name":503,"class":43},"Brigham and Women's Hospital",2,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":21,"phases":514,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":66},"100584649","probiotics-for-prevention-of-neratinib-induced-diarrhea-in-breast-cancer-patients-100584649","NCT06892093","Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients","Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.\n2. Scheduled to receive Neratinib therapy (monotherapy or in combination), based on clinical guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with an expected survival of at least 3 months.\n4. Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Resolution of any prior treatment-related toxicity to Grade ≤1 (per CTCAE v5.0), with AST and ALT ≤ 2.5 × the upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN.\n6. Adequate bone marrow function, defined as:\n\n   White blood cell count ≥ 3.0 × 10⁹\u002FL Neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum creatinine ≤ 1.5 × ULN\n7. No persistent gastrointestinal symptoms, such as hematochezia, chronic constipation, or abdominal pain.\n8. No evidence of structural gastrointestinal abnormalities confirmed by gastroscopy or other relevant examinations.\n\nExclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. Conditions that significantly impair swallowing, digestion, or gastrointestinal drug absorption.\n2. History of chronic gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), gastrointestinal tumors, or malabsorption syndromes.\n3. Severe cardiovascular diseases that may interfere with study treatment, including but not limited to:\n\n   Life-threatening arrhythmias Advanced atrioventricular block Unstable angina Clinically significant pericardial disease Myocardial fibrosis Uncontrolled hypertension\n4. Known hypersensitivity to any component of Neratinib, probiotics, placebo, or loperamide.\n5. Prior participation in any clinical trial involving investigational drugs within 4 weeks prior to enrollment, or chronic use of medications that may induce constipation within 6 months.\n6. Pregnant or lactating women, or those unwilling to use effective contraception during the study period.\n7. Any medical, psychiatric, or social condition that, in the investigator's judgment, could compromise the safety of the participant, interfere with study participation, or confound the study results.",{"count":513,"type":20},308,[515],"NA","This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.\n\nStudy Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea.\n\nPrimary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib.\n\nSecondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy.\n\nStudy Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included.\n\nEligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.",[27,518,519],"Diarrhea Caused by Drug","Neratinib",[519,521,522,26],"Probiotics","Diarrhea","2026-06-15",{"date":497,"type":37},{"date":526,"type":37},"2025-08-07",{"date":528,"type":20},"2027-12",{"name":530,"class":43},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":66},"100642519","phase-2-trastuzumab-rezetecan-neoadjuvant-therapy-in-thp-insensitive-her2-positive-early-breast-cancer-100642519","NCT07647263","Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer","An Interventional, Multicenter Study of Trastuzumab Rezetecan as Neoadjuvant Therapy in Patients With THP-Insensitive HER2-Positive Early Breast Cancer","Inclusion Criteria:\n\n* 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.\n* 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as: immunohistochemistry (IHC) 3+; or IHC 2+ with confirmed HER2 gene amplification by fluorescence in situ hybridization (FISH).\n* 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.\n* 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.\n* 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 6.Ability to understand and provide written informed consent.\n* 7.Adequate organ function as evidenced by the following laboratory values:\n* Hemoglobin ≥90 g\u002FL\n* White blood cell count ≥3.5×10⁹\u002FL\n* Platelet count ≥100×10⁹\u002FL\n* Neutrophil count ≥1.5×10⁹\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN)\n* Total bilirubin ≤1.5×ULN\n* Serum creatinine ≤1.5×ULN\n* 8.No evidence of myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥55% on echocardiogram; cardiac biomarkers (cardiac troponin I \\[cTnI\\] and B-type natriuretic peptide \\[BNP\\]) within normal limits.\n* 9.All required baseline laboratory and radiologic examinations completed prior to neoadjuvant therapy.\n* 10.No dysphagia.\n* 11.Availability of complete clinical data.\n\nExclusion Criteria:\n\n* 1.Male breast cancer or inflammatory breast cancer.\n* 2.Metastatic breast cancer (Stage IV).\n* 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.\n* 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.\n* 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.\n* 7.Receipt of radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, or major breast surgery for breast cancer within 4 weeks prior to study treatment; current or prior use of HER2-targeted monoclonal antibodies, HER2-targeted antibody-drug conjugates (ADCs), or tyrosine kinase inhibitors (TKIs).\n* 8.History of hypersensitivity or contraindication to any component of the study drugs.\n* 9.Poorly controlled cardiac symptoms or diseases, including: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n\nDementia, intellectual disability, or any psychiatric disorder that impairs the ability to understand the informed consent form.",{"count":539,"type":20},124,[23],"This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing.\n\nPatients with an inadequate response to THP are defined as those with \\\u003C50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold (\\\u003C80% tumor cell killing for HER2+\u002FHR- tumors; \\\u003C60% for HER2+\u002FHR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP.\n\nThe primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes.\n\nA total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.",[27],[26,414,544,545],"Neoadjuvant therapy","Trastuzumab rezetecan","2026-06-09",{"date":523,"type":37},{"date":549,"type":37},"2026-03-24",{"date":551,"type":20},"2031-12",{"name":553,"class":43},"The First Affiliated Hospital of Soochow University",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":21,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":66},"100643678","phase-2-pyrotinib-plus-trastuzumab-and-chemotherapy-for-her2-positive-early-breast-cancer-100643678","NCT07635342","Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer","Efficacy and Safety of Pyrotinib and Trastuzumab Combined With Pegylated Liposomal Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel for Injection Albumin Bound as Neoadjuvant Therapy for Early HER2-Positive Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 to 65 years.\n* Patients with previously untreated invasive breast cancer confirmed by pathological examination.\n* HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.\n* Clinical stage T2N0-3M0 or any T\u002FN1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.\n* At least one measurable lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function, meeting all of the following criteria:\n* Hemoglobin ≥100 g\u002FL.\n* Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n* Platelet count ≥100 × 10\\^9\u002FL.\n* Total bilirubin ≤1 × upper limit of normal (ULN).\n* Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.\n* Alkaline phosphatase ≤2.5 × ULN.\n* Blood urea nitrogen and serum creatinine ≤1.5 × ULN.\n* Left ventricular ejection fraction ≥55% by echocardiography.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of study treatment.\n* Patients must voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.\n* Concurrent receipt of any other anti-tumor therapy.\n* Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.\n* Stage IV breast cancer.\n* Breast cancer not confirmed by pathological examination.\n* History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.\n* Severe dysfunction of major organs, including the heart, liver, or kidney.\n* Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.\n* Participation in another drug clinical trial within 4 weeks before enrollment.\n* Known history of allergy to any component of the study treatment.\n* History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.\n* Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.\n* Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.\n* Clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.","65 Years",{"count":563,"type":20},182,[23],"This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.\n\nEligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.",[27],[568,412,569,570],"Neoadjuvant Therapy","Trastuzumab","Pathological Complete Response","2026-06-03",{"date":546,"type":37},{"date":574,"type":37},"2024-04-30",{"date":576,"type":20},"2029-12-31",{"name":578,"class":43},"Hebei Medical University Fourth Hospital",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":403,"enrollmentInfo":586,"targetDuration":4,"studyType":21,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":504},"100632783","phase-3-a-study-of-bl-m07d1-combined-with-pertuzumab-versus-docetaxel-plus-trastuzumab-and-pertuzumab-in-patients-with-first-line-her2-positive-recurrent-or-metastatic-breast-cancer-100632783","NCT07518173","A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;\n3. Expected survival time ≥12 weeks;\n4. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;\n5. Clear hormone receptor (HR) status;\n6. Agree to provide eligible tumor tissue specimens;\n7. Have at least one measurable target lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. Organ function levels must meet the requirements;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.\n2. Previously received ADC drug therapy with camptothecin derivatives as toxins.\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening.\n4. Concomitant pulmonary disease resulting in severely impaired lung function.\n5. History of interstitial lung disease (ILD)\u002Finterstitial pneumonia requiring corticosteroid therapy, etc.\n6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.\n7. Diagnosed with another primary malignancy within 5 years before the first dose.\n8. Newly developed deep vein thrombosis within 14 days before screening.\n9. Hypertension poorly controlled by antihypertensive medications.\n10. Patients with active central nervous system metastases.\n11. History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.\n12. History of autologous or allogeneic stem cell transplantation or organ transplantation.\n13. Previously received anthracycline therapy exceeding the prescribed dose limit.\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.\n15. Severe infection within 4 weeks prior to the first use of the study drug, etc.\n16. Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.\n17. Receiving systemic corticosteroid therapy \\>10 mg\u002Fday prednisone or equivalent prior to randomization, etc.\n18. Presence of severe neurological or psychiatric disorders.\n19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.\n20. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.\n21. Subjects planning to receive or having received live vaccines within 28 days before the first dose.\n22. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study in the investigator's opinion.",{"count":587,"type":20},596,[256],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.",[27],{"date":592,"type":37},"2026-06-04",{"date":594,"type":37},"2026-04-21",{"date":596,"type":20},"2029-12",{"name":598,"class":139},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":608,"phases":4,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":66},"100411530","identification-of-genetic-determinants-for-treatment-resistancesensitivity-andor-toxicity-in-adjuvant-setting-for-her2-positive-breast-cancer-100411530","NCT04638725","Identification of Genetic Determinants for Treatment Resistance\u002FSensitivity and\u002For Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer","SIGHER","For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria:\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable.\n* Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer\n* Given written informed consent\n\nExclusion Criteria:\n\n* Patients not able to comply to the protocol assessments for geographic, social or psychological reasons\n* Patients placed under judicial protection, guardianship, or supervision\n* History of cancer in the 5 years preceding anti-HER2 therapy initiation\n* Concomitant cancer (except for an other non metastatic cancer treated only with surgery)\n\nNote : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01\u002F01\u002F2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study.",{"count":607,"type":20},9000,"OBSERVATIONAL","This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed every six months for five years.",[27],{"date":592,"type":37},{"date":613,"type":37},"2021-12-15",{"date":615,"type":20},"2033-12-15",{"name":617,"class":43},"Centre Paul Strauss",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":624,"enrollmentInfo":625,"targetDuration":4,"studyType":21,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":66},"100638727","pilot-study-on-the-clinical-efficacy-of-focused-ultrasound-mediated-targeted-drug-delivery-system-combined-with-neoadjuvant-therapy-for-her2-positive-breast-cancer-100638727","NCT07616440","Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged 18-70 years.\n2. Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen.\n3. TNM stage T2N0-2M0.\n4. Adequate bone marrow reserve (ANC \\>1.5×10⁹\u002FL, platelets \\>100×10⁹\u002FL).\n5. Normal liver function (ALAT, ASAT, and bilirubin \\\u003C2.5× upper limit of normal).\n6. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin).\n7. Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA.\n8. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.\n9. No medical conditions that would place the subject at undue risk.\n10. Written informed consent signed by the subject.\n\nExclusion Criteria:\n\n1. Prior history of radiotherapy or chemotherapy.\n2. Pregnant or lactating patients.\n3. Presence of distant metastasis.\n4. Bilateral invasive breast cancer.\n5. Concurrent administration of other anticancer therapies or another investigational agent.\n6. inadequate physical tolerance, including significant cardiovascular, hepatic, or renal dysfunction, massive ascites, intestinal obstruction, severe infection, high fever, as well as water-electrolyte and acid-base imbalance.\n7. Patients with known hyper sensitivity to SonoVue®.","70 Years",{"count":626,"type":20},20,[515],"This study aimed to evaluate the feasibility and safety, and to observe early efficacy signals of the focused ultrasound mediated drug delivery system combined with SonoVue® in patients with HER2-positive breast cancer receiving neoadjuvant therapy by comparing its pathological complete response (pCR) rate with a matched historical cohort of HER2-positive breast cancer patients treated at our center.",[27],"2026-06-02",{"date":592,"type":37},{"date":633,"type":37},"2026-06-01",{"date":635,"type":20},"2027-01-31",{"name":637,"class":43},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":21,"phases":647,"briefSummary":648,"conditions":649,"keywords":660,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":88},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":646,"type":20},383,[98],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[650,305,27,651,652,653,654,655,169,656,657,658,659],"HER2 Mutation-Related Tumors","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[661,662,663,664,665,666,667,668,669,670,305,671],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases",{"date":592,"type":37},{"date":674,"type":37},"2024-03-25",{"date":676,"type":20},"2028-12",{"name":678,"class":139},"Iambic Therapeutics, Inc",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":685,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":95,"minAge":17,"maxAge":624,"enrollmentInfo":687,"targetDuration":4,"studyType":21,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":66},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.",{"count":688,"type":20},716,[23],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[692,26,693,694,27,178,695,696,697,698],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":701,"type":37},"2026-05-28",{"date":703,"type":37},"2022-11-01",{"date":705,"type":20},"2029-09",{"name":344,"class":43}]