[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her-2-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her-2-positive-breast-cancer":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,75,95,133],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100615993","phase-2-a-study-of-a166-in-patients-with-her2-positive-unresectable-or-metastatic-breast-cancer-100615993",false,"NCT07299825","A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs","Inclusion Criteria:\n\n1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.\n2. Breast cancer patients by histopathology and\u002For cytology documented.\n3. In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.\n4. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.\n5. At least one measurable lesion according to RECIST 1.1 criteria.\n\nExclusion Criteria:\n\n1. Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.\n2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.\n3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.\n4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.\n5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.\n6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates",[27],"Her 2 Positive Breast Cancer","RECRUITING","2026-05-05",{"date":31,"type":32},"2026-05-08","ACTUAL",{"date":34,"type":32},"2024-09-20",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":40},"100636410","phase-2-phase-ii-study-of-ultrasound-and-ctdna-guided-neoadjuvant-systemic-therapy-for-patients-with-her2-positive-early-breast-cancer-uc-her-trial-100636410","NCT07565324","Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial)","Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer","UC HER","Inclusion Criteria:\n\nDiagnosis: HER2-positive Primary Invasive Breast Cancer\n\nPatients must meet the following criteria for study entry:\n\n1. Histologically confirmed invasive breast carcinoma\n2. HER2-positive breast carcinoma\n\n   1. HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and\u002For positive by fluorescence in situ hybridization (FISH) prospectively confirmed by a pathology laboratory before study enrollment.\n   2. FISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for chromosome 17 copies.\n3. Clinical stage at presentation: T1-4, N0-3, M0 (T1N0M0 tumors will not be eligible)\n4. Patients must be willing to receive preoperative systemic chemotherapy with taxanes and HER-2-targeting treatment for at least 4 to 6 cycles.\n\n   1. Systemic therapy must consist of at least 4 to 6 cycles of chemotherapy with taxanes plus trastuzumab (TH) or\n   2. Systemic therapy must consist of at least 4 to 6 cycles of chemotherapy with taxanes plus trastuzumab and pertuzumab (THP).\n   3. After completion of 4 to 6 cycles of TH or THP, if the following clinical features and pathological characteristics are eligible for Lipo-Dox® and cyclophosphamide plus trastuzumab and pertuzumab:\n\n   c.1 Core biopsy showed the residual invasive breast cancer. c.2 Breast echo or other imaging studies disclosed no complete remission. c.3 Complete remission of core biopsy or breast echo or other imaging studies, but positive for ctDNA.\n5. Age ≥ 20 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Adequate organ function during screening, included:\n\n   1. Absolute neutrophil count ≥ 1,200 cells\u002Fmm3\n   2. Platelet count ≥ 100,000 cells\u002F mm3\n   3. Hemoglobin ≥ 9.0 g\u002FdL;\n   4. Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN)\n   5. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 ×ULN\n   6. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN\n   7. Serum total bilirubin (TBILI) ≤ 1.0 ×ULN (within normal limits)\n   8. Serum alkaline phosphatase (ALK) ≤ 1.5 ×ULN\n8. Screening LVEF ≥ 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) before receiving neoadjuvant chemotherapy with 4 to 6 courses of TH or THP and no decrease in LVEF by more than 10% absolute points from the pre-chemotherapy LVEF after 4 to 6 courses of TH or THP.\n9. For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 7 months after the last dose of study drug.\n10. Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes HB surface antigen (HBsAg) and\u002For total HB core antibody (anti-HBc) in addition to HCV antibody testing. If positive for HBsAg or positive for Anti-HBc, DNA testing for HBV will be performed. If active HBV infection is ruled out, the patient may be eligible. The most recent serologic testing must have occurred within 3 months prior to initiation of neoadjuvant therapy. If such testing has not been done, it must be performed during screening.\n11. They should receive examination of HBV DNA to document no active HBV activation (if HBeAg-positive, or HBeAg-negative but abnormal liver function accompanied by ALT ≥ 2 normal limits during the half a year and HBV DNA \\> 2000 IU\u002Fml: indication of HBV activation). If test of HBsAg is positive and inactive, and they should receive prophylactic anti-HBV drugs during the enrollment period of this clinical trial.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer.\n2. History of any prior (ipsilateral- or contralateral) breast cancer except lobular carcinoma in situ.\n3. History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.\n4. Patients for whom radiotherapy would be recommended for breast cancer treatment, but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation).\n5. Current NCI common terminology criteria for adverse events (CTCAE) (Version 4.0): Grade ≥ 2 peripheral neuropathy.\n6. Cardiopulmonary dysfunction as defined by any of the following:\n\n   History of NCI CTCAE (Version 4.0): Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II.\n7. Prior treatment with anthracycline or Lipo-Dox®\n8. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers).\n9. For female patients, current pregnancy and\u002For lactation. 10. Any known active liver disease, for example, due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis.\n\n   * Patients who have positive HBV or HCV serologies without known active disease must meet the eligibility criteria for liver function on at least two consecutive occasions, separated by at least 1 week, within the 30 days-screening period.","FEMALE","20 Years",{"count":52,"type":21},54,[24],"Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined with chemotherapy, certain patients did not achieve pCR after receiving dual blockade or single blockade targeting HER2 combined with taxanes.\n\nBased on the cardiac safety and promising ORR rate of the regimens consisting of PLD and cyclophosphamide and trastuzumab in treating patients with HER2-positive breast cancer in the neoadjuvant or metastatic setting, the investigators hypothesized that dual blockades targeting HER2, trastuzumab and pertuzumab, combined with PLD and cyclophosphamide, will not only increase the pCR rate but also cause less cardiotoxicity for participants with residual cancer via core biopsy or non-clinical CR after receiving taxanes plus trastuzumab and pertuzumab or taxanes plus trastuzumab. The investigators also showed that ctDNA served as the surrogate prognostic marker for participants with HER2-positive EBC who received neoadjuvant trastuzumab-based regimens.\n\nIn this study, the investigators will explore whether the combination of PLD (Lipo-Dox®, Liposomal Doxorubicin Injection), cyclophosphamide, trastuzumab, and pertuzumab can increase the pCR rate of participants with HER2-positive EBC if they have residual cancers (core biopsy, non-clinical CR, or positive ctDNA) after receiving a trastuzumab and taxanes-based NAT regimen. In addition, the cardiac safety, adverse effects, and clearance of ctDNA will be explored for these patients. The investigators further assess the feasibility of VAB (before operation) in these participants who achieved negative ctDNA after receiving Lipo-Dox® plus cyclophosphamide, trastuzumab, and pertuzumab.",[56],"HER-2 Positive Breast Cancer",[58,59,60,61,62,63],"HER2","Breast cancer","Lipodox","Cyclophosphamide","Trastuzumab","Pertuzumab","NOT_YET_RECRUITING","2026-04-27",{"date":67,"type":32},"2026-05-04",{"date":69,"type":21},"2026-04-30",{"date":71,"type":21},"2032-12-31",{"name":73,"class":74},"National Taiwan University Hospital","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100631914","phase-2-concurrent-neoadjuvant-chemoendocrine-therapy-in-her2-breast-cancer-100631914","NCT07506876","Concurrent Neoadjuvant Chemo\u002FEndocrine Therapy in HER2+ Breast Cancer","Inclusion Criteria:\n\n1. Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)\n\n   1. Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy\u002FHER2 directed therapy\n   2. Choice of endocrine therapy will be determined by the treating and\u002For enrolling physician\n2. Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP\n3. Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint\u002FBluePrint performed on initial biopsy\n\nExclusion Criteria:\n\n1. Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.\n2. Patients with non-breast cancer within prior 2 years\n3. Patients with breast cancer within prior 5 years\n4. Patients with recurrent breast cancer\n5. Patients with stage IV breast cancer",{"count":82,"type":21},30,[24],"The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.\n\nThe purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery",[86,56],"Breast Cancer - Infiltrating Ductal Carcinoma",{"date":88,"type":32},"2026-05-01",{"date":65,"type":32},{"date":91,"type":21},"2027-12",{"name":93,"class":74},"Legacy Health System",4,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":49,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100634654","real-world-bicohort-observational-study-of-a-pertuzumab-biosimilar-in-the-treatment-of-breast-cancer-in-the-neoadjuvant-setting-and-in-first-line-metastatic-disease-100634654","NCT07542496","Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease","PERTUREAL","Inclusion Criteria:\n\n* Age ≥ 19 years at the time of inclusion;\n* Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH\u002FCISH\u002FSISH);\n* Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;\n* Treatment prescribed as part of routine clinical care (outside of a clinical trial);\n* Patient informed and having provided written informed consent.\n\nExclusion Criteria:\n\n* Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);\n* Treatment administered as part of an interventional clinical trial;\n* History of severe allergy or known contraindication to pertuzumab;\n* Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.","19 Years",{"count":104,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.",[108,27],"Breast Cancer",[110,111,112,113,63,108,114,115,116,117,118,119,120,121,122],"Algerian Study","Real-world data","Algeria","Biosimilar","Cancer","Breast cancer in Algerian patients","HER2-Positive Breast Cancer","Neoadjuvant Therapy","Anti-HER2 Therapy","Cohort Study","Non-Interventional Study","HER2-Targeted Therapy","Observational Study","2026-04-14",{"date":125,"type":32},"2026-04-21",{"date":127,"type":32},"2026-01-15",{"date":129,"type":21},"2027-01-15",{"name":131,"class":74},"Société Algérienne de Formation et Recherche en Oncologie",2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":40},"100624204","gut-microbiome-changes-during-abemaciclib-therapy-in-breast-cancer-100624204","NCT07406594","Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer","MICRO-VERZ: MICRObiome Changes During VERZenio Therapy","MICRO-VERZ","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.\n* Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\n  * Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.\n* Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.\n* Known allergy or intolerance to resistant starch or any component of the study supplement.\n* Pregnant or breastfeeding individuals.\n* Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.",{"count":142,"type":21},12,[144],"NA","Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms.\n\nThe purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely.\n\nInformation gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.",[108,56],[148],"microbiome","2026-02-05",{"date":151,"type":32},"2026-02-12",{"date":153,"type":21},"2027-10",{"date":155,"type":21},"2031-10",{"name":157,"class":74},"University of Vermont Medical Center"]