[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-neoplasm-of-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-neoplasm-of-breast":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,72,96,128,153],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100638410","collection-of-csf-samples-from-participants-with-metastatic-triple-negative-breast-cancer-tnbc-and-her2-breast-cancer-with-no-prior-history-nor-active-radiographically-detectable-brain-metastases-100638410",false,"NCT07619534","Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases","Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer","* INCLUSION CRITERIA:\n* Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.\n* Participants must be able to undergo lumbar puncture (LP) and brain MRI.\n* Women age \\>= 18 years\n* Adequate organ function as defined below:\n\n  * Creatinine \\\u003C=1.5 x institutional upper limit of normal (ULN)\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n\\- Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior history or current MRI-detected brain metastasis or leptomeningeal disease\n* Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.\n* Pregnancy","ALL","18 Years","120 Years",{"count":20,"type":21},139,"ESTIMATED","OBSERVATIONAL","Background:\n\nBreast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.\n\nObjective:\n\nTo collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.\n\nEligibility:\n\nPeople aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.\n\nDesign:\n\nParticipants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.\n\nParticipants will come to the NIH clinic to have their samples collected:\n\n* Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.\n* Blood.\n* Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.\n* Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.\n\nParticipants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples.",[25,26,27,28],"Breast Cancer","Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast",[30,31,32,33],"Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection","NOT_YET_RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":21},"2026-08-26",{"date":42,"type":21},"2034-07-01",{"name":44,"class":45},"National Cancer Institute (NCI)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100598103","a-synthetic-lethality-focused-algorithm-to-identify-therapeutic-options-in-advanced-metastatic-breast-cancer-synthesis-breast-100598103","NCT07067138","A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)","An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)","-INCLUSION CRITERIA:\n\n1. Participants must have a histologically confirmed diagnosis of metastatic breast cancer. Note: Pathology testing outside NIH will be accepted for eligibility purposes.\n2. Participant tumor subtypes will be enrolled as follows:\n\n   * TNBC Cohort: TNBC will be defined as ER \\\u003C 10% or PR \\\u003C 10% by immunohistochemistry (IHC).\n   * Endocrine-Refractory Cohort: HR+ (ER+ and\u002For PR+) will be defined as ER \\>= 10% or PR \\>= 10% by IHC.\n   * For both cohorts, HER2 will be considered negative if not amplified as per ASCOCAP guidelines per IHC\u002FFISH. Note: HER2-low status will be regarded in accordance with NCCN guidelines (in which this designation serves as a predictive marker for trastuzumab deruxtecan, but participants are otherwise not considered eligible for other HER2-directed therapies).\n3. Participants must have been treated with at least one (1) line of systemic therapy after diagnosis of metastatic disease, anticipate or have progressive disease or adverse events requiring discontinuation of their current regimen, and must not be able to transition to another approved systemic therapy shown to improve overall survival.\n\n   -Participants with HR+ disease must be deemed refractory to endocrine therapy per their clinical team, with concordance by study team.\n\n   Note: Participants who cannot receive or decline to receive standard therapy that has been shown to prolong overall survival, or if such therapy is not deemed in the participant s best interest, will be eligible, if other eligibility criteria are met. If appropriate, participants may remain on treatment during biopsy, screening and initial tissue review\u002Ftesting for this study.\n4. Participants must have measurable disease per RECIST v1.1. Note: Palliative radiotherapy to site(s) of disease may be completed during screening as long as disease outside of the planned sites of radiation is available for response assessment.\n5. Archival tumor (preserved via FFPE) must be available from a biopsy performed within the past 6 months. The timeframe of 6 months is required to optimize reliability of ENLIGHT results. It is assumed that a participant has had no more than one (1) line of systemic treatment since the last biopsy. Participants who have had multiple intervening lines of therapy since biopsy was obtained will be reviewed by the study team to determine if another biopsy may be needed. Note: If archival tissue is not available within that timeframe, tissue from the next scheduled biopsy can be sent to NIH for testing. If it is not possible for a biopsy to be scheduled, the study team will evaluate the possibility of a biopsy being performed at the NIH for enrollment purposes.\n6. Age \\>=18 years.\n7. ECOG performance status \\\u003C2 (Karnofsky \\>60%)\n8. Participants must have organ and marrow function as defined below:\n\n   * Hemoglobin \\>= 8g\u002FdL\n   * Absolute neutrophil count \\>= 1,200\u002FmcL\n   * Platelets \\>=75,000\u002FmcL\n   * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (In the case of known Gilbert's Disease, total bili \\>1.5 may be considered.)\n\n   (For participants with known liver involvement, \\\u003C=3x institutional upper limit of normal)\n\n   -AST(SGOT)\u002FALT(SGPT) \\\u003C= 3x institutional upper limit of normal\n\n   (For participants with known liver involvement, \\\u003C=5x institutional upper limit of normal)\n\n   -Creatinine \\\u003C 1.5 x normal institutional limits OR Creatinine clearance \\>=30 mL\u002Fmin\u002F1.73 m2\n9. Ability to take oral medications.\n10. Participants with an existing diagnosis of diabetes or hypertension, must have disease well-controlled with at least annual physician follow-up.\n11. Women of child-bearing potential and men with a partner of child-bearing potential must be willing to use appropriate contraception in the event that they match to a therapy that requires such. The duration of contraception use will depend on the therapy assigned.\n12. Willingness to comply with required study procedures and visits for the duration of study.\n13. Participants with asymptomatic brain metastases may be included if metastases have been previously treated with local therapy including radiation at least 4 weeks prior to first dose of treatment and there is no indication for additional local therapy (including active progression).\n14. Participants with human immunodeficiency virus (HIV) must be on an effective anti-retroviral therapy with undetectable viral load for at least the last 6 months.\n15. Participants with evidence of chronic hepatitis B virus (HBV) infection, must have HBV viral load that is undetectable on suppressive therapy, if indicated.\n16. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection must be currently on treatment, with undetectable HCV viral load.\n17. Participants with a prior or concurrent malignancy are eligible if the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the off-label therapies offered on this study in the opinion of the Principal Investigator (PI) and are otherwise eligible for this trial.\n18. Participants with current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Note: To be eligible for this trial, participants should be class 2B or better.\n19. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants in active visceral crisis, symptomatic brain metastases requiring local therapy, or active leptomeningeal disease given the time required for testing and therapy selection.\n2. Participants with uncontrolled intercurrent illness evaluated by physical exam and chemistries or situations that would limit compliance with study requirements, interpretation of results or that could increase risk to the participant.\n3. Participants with the following active cardiac conditions: symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia (per medical record).\n4. Participants with lung disease requiring continuous oxygen supplementation.\n5. Participants with decompensated cirrhosis and\u002For end-stage kidney disease on dialysis.\n6. Participants with positive serum or urine beta-HCG pregnancy test performed at screening.\n7. Participants who are unable to provide tissue specimens of sufficient quality for use in this study. Quality of DNA and RNA is determined during screening. This may be due to issues with biopsy sample collection, inadequate RNA extraction, or quality control failure. Participants may be re-screened if initial specimens are not adequate, if they are amenable to re-biopsy, and additional site(s) of disease for adequate re-sampling are available.",{"count":55,"type":21},175,"INTERVENTIONAL",[58],"NA","Background:\n\nBreast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively.\n\nObjective:\n\nTo test whether ENLIGHT can find better treatments for aggressive breast cancers.\n\nEligibility:\n\nPeople aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment.\n\nDesign:\n\nParticipants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500).\n\nParticipants will be assigned to 1 of 3 groups based on the algorithm search results:\n\nGroup 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors.\n\nGroup 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs.\n\nGroup 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends.\n\nParticipants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.",[25,26,27,28],[62,30,63,64],"ENLIGHT","Her2","NSR device","RECRUITING",{"date":37,"type":38},{"date":68,"type":38},"2026-02-23",{"date":70,"type":21},"2029-08-04",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":46},"100412719","swedish-ibrance-registries-insights-siri-100412719","NCT04654208","Swedish Ibrance Registries Insights (SIRI)","Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)","SIRI","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)\n2. Age ≥18 years at index date\n\nExclusion Criteria:\n\nThere are no exclusion criteria",{"count":81,"type":21},1500,"The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.",[28],[85],"metastatic breast cancer (MBC)","2026-03-29",{"date":88,"type":38},"2026-03-31",{"date":90,"type":38},"2020-12-15",{"date":92,"type":21},"2026-05-31",{"name":94,"class":95},"Pfizer","INDUSTRY",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":56,"phases":106,"briefSummary":108,"conditions":109,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100535416","phase-1-trail-r2-and-her2-bi-specific-chimeric-antigen-receptor-car-t-cells-for-the-treatment-of-metastatic-breast-cancer-100535416","NCT06251544","TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer","(TRAILBLASER) TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor T Cells for the Treatment of Metastatic Breast Cancer","Procurement Inclusion Criteria:\n\n1. Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer.\n2. HER2 tumor expression1+, 2+ or 3+ by IHC\n3. The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n1. Patients between ages 18 and 80 years old with a diagnosis of either stage IV breast cancer or locally recurrent unresectable breast cancer. Disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n2. Measurable or evaluable disease per RECIST 1.1 criteria.\n3. HER2 tumor expression 1+, 2+ or 3+ by IHC.\n4. Bilirubin ≤ 3x upper limit of normal.\n5. AST and ALT ≤ 3x upper limit of normal\n6. Hemoglobin ≥ 7 g\u002Fdl (may be transfused values)\n7. Serum creatinine \\\u003C 2 x the upper limit of normal.\n8. Pulse oximetry of \\> 90% on room air.\n9. Off conventional or investigational therapy for 3 weeks prior to study entry.\n10. ECOG Performance Status ≤ 2\n11. The patient is able to understand and give informed consent to study related procedures and treatments.\n\nProcurement Exclusion Criteria:\n\n1. Known pregnancy or actively breast feeding.\n2. Active and uncontrolled bacterial, viral, or fungal infection.\n3. Patients with current use of systemic corticosteroids (Prednisone equivalent \\>0.5mg\u002Fkg\u002Fday).\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%)\n5. Patients with brain metastases that are progressing.\n\nTreatment Exclusion Criteria:\n\n1. Pregnant or breast feeding\n2. Active and uncontrolled bacterial, viral or fungal infection\n3. Patient with current use of systemic corticosteroids (prednisone equivalent \\>0.5 mg\u002Fkg\u002Fday.\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%).\n5. Patients with brain metastases that are progressing","80 Years",{"count":105,"type":21},27,[107],"PHASE1","The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer.\n\nPatients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells.\n\nThe body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients.\n\nPrevious research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment.\n\nInvestigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2.\n\nAlso, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells).\n\nThe HTR2 T cells are an investigational product not approved by the Food and Drug Administration.",[25,110,111,28,112,113,114,115],"Tumor, Breast","Breast Tumor","Mammary Cancer","Mammary Neoplasm","Mammary Neoplasms, Human","Neoplasm, Breast",[117],"HER2 positive","2026-03-02",{"date":120,"type":38},"2026-03-04",{"date":122,"type":21},"2026-06",{"date":124,"type":21},"2044-01",{"name":126,"class":127},"Baylor College of Medicine","OTHER",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":135,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":56,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100321368","confirmatory-clinical-evaluation-of-novilase-laser-therapy-for-focal-destruction-of-malignant-breast-tumors-100321368","NCT03463954","Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors","Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)","Inclusion Criteria:\n\n* Females, aged 18 years and older\n* Able to give written informed consent herself\n* Definitive pathologic diagnosis by needle core biopsy\n* Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic\n* No more than 10 mm of calcifications confined to the tumor on imaging\n* Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images)\n* Tumor is well visualized on MRI\n* Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site\n* Tumor with less than 25% intraductal component, as determined by core biopsy\n* No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy\n* Subject weight limited to ≤300 lbs. or ≤136 kg\n* Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician\n\nExclusion Criteria:\n\n* Subject younger than 18 years of age\n* Pregnant or breast-feeding\n* Tumor poorly visualized by ultrasound or x-ray mammography imaging\n* Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and\u002For acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) \\\u003C30ml\u002Fmin\u002F1.73 sq. meters)\n* Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)\n* History of severe asthma\n* Tumor measuring greater than 15 mm in longest dimension\n* Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm.\n* Advanced stage breast cancer\n* Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease\n* Tumor with only DCIS with microinvasion\n* Extensive intraductal component in lesion (i.e., \\>25%) as determined by core biopsy\n* Subject who is known to be BRCA positive\n* Tumor that is ER\u002FPR\u002FHER2 negative (TNBC)\n* Inability to lie in prone or supine position for one hour\n* Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial\n* Subject without a definitive HER2 test according to ASCO\u002FCAP guidelines","FEMALE",{"count":137,"type":21},122,[58],"Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.",[28],[142],"less than or equal to 15 mm","2026-02-17",{"date":145,"type":38},"2026-02-19",{"date":147,"type":38},"2023-08-09",{"date":149,"type":21},"2027-03-30",{"name":151,"class":95},"Novian Health Inc.",13,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":135,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":56,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":46},"100413921","accelerated-partial-breast-irradiation-versus-standard-or-hypofractionated-whole-breast-irradiation-in-early-breast-cancer-after-breast-conserving-surgery-100413921","NCT04669873","Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery","Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery","LAPIDARY","Inclusion Criteria:\n\n* Information to the patient and signed informed consent;\n* Women aged ≥50 years\n* Breast conserving surgery\n* Pathologic tumor size \\\u003C 3 cm (maximum microscopic diameter of the invasive component)\n* Invasive adenocarcinoma (except classic invasive lobular carcinoma)\n* Unifocal disease\n* Histopathologic grades I or II\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Lymphovascular invasion absent\n* Negative axillary lymph nodes\n* Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)\n* No prior breast or mediastinal radiotherapy\n* No hematogenous metastases\n\nExclusion Criteria:\n\n* Previous malignancy (except non-melanomatous skin cancer)\n* Mastectomy\n* Classical-Type Invasive Lobular Carcinoma\n* Neoadjuvant chemotherapy\n* Human Epidermal growth factor Receptor-type 2 positive (HER2+)\n* Triple-negative breast cancers\n* Intravascular lymphoma present\n* Contraindications to radiotherapy.\n* No geographical, social or psychologic reasons that would prevent study follow","50 Years","90 Years",{"count":164,"type":21},36,[58],"Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.\n\nThere are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.",[28],[25,169,170,171],"Radiotherapy","Hypofractionated","Breast-conserving surgery","2021-03-04",{"date":174,"type":38},"2021-03-08",{"date":172,"type":38},{"date":177,"type":21},"2026-12-31",{"name":179,"class":127},"Instituto Brasileiro de Controle do Cancer"]