[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-advanced-breast-cancer":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,68,92,119,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176",false,"NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol","ALL","18 Years",{"count":19,"type":20},392,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[26,27,28,29,30,31,32,33,34,35,36],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","RECRUITING","2026-06-18",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2024-10-29",{"date":63,"type":20},"2028-11",{"name":65,"class":66},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)","INDUSTRY",40,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100596584","phase-3-tqb2930-injection-for-the-treatment-of-her2-positive-advanced-breast-cancer-100596584","NCT07047365","TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer","A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign the informed consent form;\n* Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy \\>3 months;\n* Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;\n* Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;\n* At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);\n* Willing to receive one of the investigator-selected chemotherapy regimens;\n* Adequate organ function;\n* Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n* Concurrent Diseases and Medical History:\n\n  * Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);\n  * Uncontrolled toxicities (\\>CTCAE Grade 1) from prior therapies (excluding alopecia);\n  * Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;\n  * Non-healing wounds or fractures;\n  * Arterial\u002Fvenous thromboembolic events within 6 months before randomization;\n  * History of drug abuse or psychiatric disorders that may affect compliance;\n  * Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) \\>160 mmHg despite treatment);\n  * ≥Grade 2 myocardial ischemia\u002Finfarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);\n  * Active or uncontrolled severe infections (≥CTCAE Grade 2);\n  * Known chronic hepatitis B;\n  * Active syphilis infection;\n  * Renal failure requiring hemodialysis\u002Fperitoneal dialysis;\n  * Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;\n  * Poorly controlled diabetes;\n  * Urine protein ≥++ on dipstick with 24-hour urine protein \\>1.0 g;\n  * Epilepsy requiring medication.\n* Tumor-Related Conditions and Treatments:\n\n  * Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization (or within 5 half-lives of prior drugs, whichever is shorter);\n  * Chinese herbal medicines with approved antitumor indications (per National Medical Products Administration (NMPA) labeling) within 2 weeks;\n  * Severe Bone Lesions from bone metastases;\n  * Untreated brain metastases, Leptomeningeal metastases, or carcinomatous meningitis;\n  * Prior HER2-targeted therapy-induced Left Ventricular Ejection Fraction (LVEF) decline to \\\u003C50% or absolute reduction \\>15%;\n  * Uncontrolled or symptomatic Hypertension requiring ongoing bisphosphonates;\n  * Uncontrolled cancer-related pain;\n  * Existed Lymphangitis Carcinomatosa or uncontrolled effusions;\n  * Use of Immunosuppressant or systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent) within 2 weeks.\n* Severe hypersensitivity to monoclonal antibodies;\n* Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;\n* Any condition deemed by the investigator to jeopardize subject safety or study completion.","75 Years",{"count":77,"type":20},416,[79],"PHASE3","TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.",[36],"2026-06-02",{"date":84,"type":59},"2026-06-03",{"date":86,"type":59},"2025-07-25",{"date":88,"type":20},"2028-12",{"name":90,"class":66},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",75,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":99,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100600677","phase-2-trastuzumab-rezetecan-combined-with-radiotherapy-versus-trastuzumab-rezetecan-in-the-treatment-of-her2-positive-advanced-breast-cancer-with-brain-metastases-100600677","NCT07100600","Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases","An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases","Inclusion Criteria:\n\n1. Females ≥18 yrs old;\n2. Pathologically confirmed HER2-positive advanced breast cancer;\n3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;\n4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;\n5. Life expectancy is not less than 6 months.\n6. Adequate function of major organs.\n\nExclusion Criteria:\n\n1. Subjects with leptomeningeal metastasis\n2. CNS complications requiring emergency neurosurgical intervention\n3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;\n4. Suffering from heart disease that is not well controlled or having clinical symptoms\n5. History of clinically significant lung disease；\n6. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.\n7. Female subjects during pregnancy and lactation\n8. Any other conditions that researchers believe that patients are unsuitable for this study.","FEMALE",{"count":101,"type":20},224,[103],"PHASE2","A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).",[36,106,107],"Brain Metastases","Radiotherapy","2025-08-06",{"date":110,"type":59},"2025-08-11",{"date":112,"type":20},"2025-08-30",{"date":114,"type":20},"2032-12-30",{"name":116,"class":117},"Henan Cancer Hospital","OTHER_GOV",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100508554","phase-3-dp303c-in-patients-with-her2-positive-advanced-breast-cancer-100508554","NCT05901935","DP303c in Patients With HER2-positive Advanced Breast Cancer","A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine\u002FCapecitabine in of HER2-positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign the informed consent;\n2. Age≥18 years old;\n3. Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology;\n4. Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);\n5. Received at least 2 lines of systemic therapy for unresectable locally advanced, recurrent, or metastatic diseases;\n6. Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;\n7. At least one assessable lesion at the baseline;\n8. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Patients with adequate organ function;\n10. Life expectancy ≥ 12 weeks;\n11. Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. History of any other malignant tumors within three years\n3. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0);\n4. The presence of active inflammatory bowel disease, chronic diarrhoea, short bowel syndrome or history of other gastrointestinal diseases or treatments that may affect intestinal absorption;\n5. Received systemic anti-tumor therapy within 28 days before randomization, traditional Chinese medicine treatment with tumor indications approved by the National Medical Administration (NMPA) and palliative radiotherapy within 2 weeks before randomization;\n6. Major organ surgery (excluding needle biopsy) within 28 days before randomization;\n7. The cumulative amount of previous exposure to anthracyclines has reached the dosage;\n8. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.\n9. History of LVEF \\\u003C 40%, symptomatic congestive heart failure (CHF),.\n10. Serious or uncontrolled cardiovascular disease;\n11. History of (non-infectious) interstitial lung disease\u002Fpneumonitis requiring steroid hormone therapy;\n12. Patients who currently have corneal diseases that require medication or surgical intervention;\n13. Peripheral neuropathy ≥ grade 3 (refer to NCI CTCAE 5.0);\n14. Active infections requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before randomization;\n15. Active hepatitis B or C;\n16. History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive;\n17. Known hypersensitivity or contraindication to the active ingredients or excipients of the study drugs;\n18. Treated with strong CYP3A inhibitors or strong CYP3A inducers before randomization;\n19. There are other circumstances that may interfere with the subject's participation in the study procedures or do not meet the subject's maximum benefit from participating in the study or affect the study results.",{"count":127,"type":20},420,[79],"This is a study of DP303c in patients with HER2-positive advanced breast cancer.",[36],"NOT_YET_RECRUITING","2023-06-04",{"date":134,"type":59},"2023-06-13",{"date":136,"type":20},"2023-07",{"date":138,"type":20},"2028-07",{"name":140,"class":66},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":118},"100505057","efficacy-and-safety-of-inetetamab-combined-with-pyrotinib-and-vinorelbine-in-abc-100505057","NCT05856383","Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC","Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in the Treatment of Advanced Breast Cancer","HER2-VIP","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. The HER2 positive advanced breast cancer confirmed by cytology or histology must meet the following conditions at the same time:\n\n(1) HER2 positive is defined as\\>10% of immunoreactive cells with an immunohistochemical (IHC) score of 3 or an in situ hybridization (ISH) result of HER2 gene amplification (2) Advanced breast cancer is defined as locally advanced breast cancer or metastatic breast cancer that cannot be removed by radical surgery confirmed by researchers; 3. The functional level of the main organs has been evaluated by the researchers to withstand chemotherapy, anti HER2 monoclonal antibodies, and anti HER2 TKI drugs. The LVEF and QT intervals measured by echocardiography or MUGA are within a clinically acceptable safety range. If the survival benefits of the treatment value are assessed by the researcher to be greater than the risks faced, the admission conditions for the specific organ function level can be appropriately relaxed by the researcher, but the reasons need to be explained in the medical record; 4. ECOG score: 0-2 points; 5. Voluntarily sign the informed consent form for this study. 6. Contraception during the study period and within 6 months after treatment, non lactation.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. At the same time or in the past five years, patients with one or more malignant tumors with metastatic capacity or potential other than HER2 positive breast cancer, but not including cured cervical carcinoma in situ, thyroid cancer, skin basal cell carcinoma or squamous cell carcinoma. For other malignant tumors occurring within a period of more than 5 years from this treatment, if only cured by surgery, they are allowed to be included.\n3. Persons with a known history of allergy to the drug components of this protocol;\n4. Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases;\n5. The researcher believes that it is not suitable for inclusion.",{"count":150,"type":20},100,"OBSERVATIONAL","This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.",[36],[155],"Advanced breast cancer，HER2-positive","2023-05-03",{"date":158,"type":59},"2023-05-12",{"date":160,"type":59},"2022-03-16",{"date":162,"type":20},"2027-12-31",{"name":164,"class":165},"Zhejiang Cancer Hospital","OTHER"]