[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-early-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-early-breast-cancer":120},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,75,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100493413","phase-2-neoadjuvant-therapy-with-trastuzumab-deruxtecan-versus-chemotherapytrastuzumabpertuzumab-in-her2-early-breast-cancer-100493413",false,"NCT05704829","NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Trastuzumab-deruxtecan Versus Pacli-\u002FDocetaxel+Carboplatin+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer","ADAPTHER2-IV","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all the following criteria:\n\n1\\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines) 2. Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm) AND cN0; cT1a\u002Fb, cN0 excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (\\>3 - ≤5cm), cN0) 3c. Cohort 3: intermediate- to high-risk for recurrence as per investigator´s decision, (recommendation: clinical stage II (cT2, cN0); cT1c, cN0 only if neoadjuvant treatment intended) 4. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate bone marrow and organ function within 14 days before randomisation as defined by the following laboratory values:\n\n* absolute neutrophil count ≥ 1.5 × 109\u002FL,\n* platelets ≥ 100 × 109\u002FL,\n* haemoglobin ≥ 9.0 g\u002FdL:\n* estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin by a Cockcroft-Gault formula,\n* INR ≤ 1.5,\n* serum creatinine \\\u003C 1.5 mg\u002FdL,\n* total bilirubin \\\u003C ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN,\n* aspartate transaminase (AST) \\\u003C 2.5 × ULN,\n* alanine transaminase (ALT) \\\u003C 2.5 × ULN. 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) Post-menopausal status is accepted for women, who at the time of initiation of study medication, either\n* had underwent bilateral oophorectomy, or\n* are ≥ 60 years of age, or\n* are \\\u003C 60 years of age and amenorrhoeic for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression)\n* and\u002For whose FSH- and oestradiol-blood values are within the postmenopausal range per local laboratory normal range.\n\n  10\\. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n\nExclusion Criteria:\n\nPatients eligible for inclusion in this study must not meet any of the following criteria:\n\n1. 1\\. Non-operable breast cancer including inflammatory breast cancer\n2. cT1a\u002Fb, cN0 breast cancer\n3. Any previous history of invasive breast cancer\n4. Primary malignancies within 5 years, with the exception of\n\n   * adequately resected non-melanoma skin cancer\n   * curatively treated in-situ disease\n5. Any evidence for existing metastatic disease (confirmed by CT Thorax\u002FAbdomen, bone scan, or other methods according to clinical practice\n6. Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons)\n7. Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry\n8. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study\u002Finadequate organ function\n9. Reasons indicating risk of poor compliance\n10. Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 7 months after stopping the treatment.\n11. Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.\n12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n13. Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out MI.\n14. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) based on average of the screening 12-lead ECG.\n15. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n16. Lung criteria:\n\n    * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\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 randomisation.\n    * Prior pneumonectomy (complete)\n    * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n17. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).\n18. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or carboplatin.\n\n    Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP.\n19. Known allergy or hypersensitivity to study treatment (T-DXd), to comparator (SoC-) treatment, or any of the study drug \u002F comparator (SoC-) excipients.\n20. History of severe hypersensitivity reactions to other monoclonal antibodies.\n21. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant","FEMALE","18 Years",{"count":20,"type":21},702,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.\n\nADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).",[27],"HER2-positive Early Breast Cancer",[29,30,31,32,33,34,35,36,37],"HER2+","T-DXd","Trastuzumab-deruxtecan","pCR","intermediate risk","high risk","low risk","recurrence","neoadjuvant","RECRUITING","2026-06-05",{"date":41,"type":42},"2026-06-09","ACTUAL",{"date":44,"type":42},"2024-02-05",{"date":46,"type":21},"2030-09",{"name":48,"class":49},"West German Study Group","OTHER",44,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100619113","phase-2-neoadjuvant-trastuzumab-rezetecan-plus-pertuzumab-or-nab-paclitaxel-carboplatin-trastuzumab-and-pyrotinib-after-suboptimal-response-to-neoadjuvant-dual-her2-targeted-therapy-combined-with-chemotherapy-in-her2-positive-early-breast-cancer-100619113","NCT07340398","Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer","Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer: A Response-Guided Phase II Study (TAYLOR)","TAYLOR","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n3. Primary tumor size \\>1 cm.\n4. Histologically confirmed invasive breast cancer, clinically staged as:\n\n   * Stage I (T1cN0M0)\n   * Stage II (T1cN1M0, T2N0-1M0 or T3N0M0)\n   * Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0)\n5. HER2-positive status: IHC 3+ or IHC 2+ with positive ISH.\n6. Adequate major organ function:\n\n   1. Hematology (no transfusion or hematopoietic growth factors, e.g., G-CSF, within 14 days):\n\n      * Hemoglobin ≥100 g\u002FL\n      * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL\n      * Platelet count ≥100 × 10⁹\u002FL\n   2. Biochemistry:\n\n      * Total bilirubin ≤1.5 × ULN\n      * ALT and AST ≤1.5 × ULN; ALP ≤2.5 × ULN\n      * BUN and creatinine ≤1.5 × ULN\n   3. Cardiac function: LVEF ≥55% by echocardiography\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for 8 weeks after the last dose.\n8. Voluntary written informed consent and willingness to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Prior anti-tumor therapy for breast cancer, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.\n2. Concurrent administration of any other anti-tumor treatment.\n3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.\n4. Breast cancer not confirmed histologically.\n5. History of other malignancy within the past 5 years, except successfully treated cervical carcinoma in situ.\n6. Severe dysfunction of major organs (heart, liver, kidney).\n7. Conditions affecting oral drug administration or absorption, e.g., inability to swallow, chronic diarrhea, or intestinal obstruction.\n8. Participation in another investigational drug trial within 4 weeks prior to enrollment.\n9. Known hypersensitivity to study drug components; history of immunodeficiency (HIV positive, active HCV, active hepatitis B, other congenital\u002Facquired immunodeficiency) or prior organ transplantation.\n10. History of clinically significant cardiac disease, including:\n\n    1. Arrhythmia requiring medication\n    2. Myocardial infarction\n    3. Heart failure\n    4. Other cardiac conditions deemed unsuitable for study participation by the investigator\n11. Pregnant or breastfeeding women, or women of childbearing potential who test positive at baseline or are unwilling to use effective contraception throughout the study.\n12. Any condition that, in the investigator's judgment, poses serious risk to patient safety or may interfere with study completion (e.g., uncontrolled severe hypertension, uncontrolled diabetes, active infection).\n13. History of neurological or psychiatric disorders (e.g., epilepsy or dementia) or any other condition the investigator considers incompatible with study participation.","75 Years",{"count":61,"type":21},200,[24],"This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.",[27],"2026-01-19",{"date":67,"type":42},"2026-01-21",{"date":69,"type":42},"2025-12-25",{"date":71,"type":21},"2031-01-01",{"name":73,"class":49},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100507166","phase-3-ec-thp-versus-tcbhp-in-her2-positive-lymph-node-positive-early-breast-cancer-100507166","NCT05883852","EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer","A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carboplatin Plus Trastuzumab and Pertuzumab (TCbHP) in the Adjuvant Treatment","Inclusion Criteria:\n\n* Women aged 18-70；\n* 0-1 for ECOG；\n* Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；\n* No gross or microscopic tumor remains after surgical resection；\n* Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH\u002FCISH test positive (with amplification) is defined as HER2 positive；\n* Postoperative pathological stage pT1-4N1-3M0；\n* Did not receive neoadjuvant chemotherapy in the past；\n* The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；\n* No peripheral neuropathy；\n* Good postoperative recovery, at least 1 week interval between operation；\n* The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g\u002FL (no blood transfusion within 14 days); ANC ≥1.5×109 \u002FL; PLT ≥100×109 \u002FL; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；\n* Contraception during treatment for women of reproductive age；\n* Cardiac function: LVEF\\>50% for ultrasound examination；\n* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。\n\nExclusion Criteria:\n\n* Bilateral breast cancer or carcinoma in situ DCIS\u002FLCIS；\n* Have received chemotherapy for advanced disease；\n* Transfer of any part；\n* If any tumor \\>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；\n* Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；\n* Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；\n* Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；\n* The patient has been enrolled in other clinical trials；\n* Patients with severe systemic disease and\u002For uncontrolled infection were unable to be enrolled in the study；\n* LVEF\\\u003C50% (cardiac ultrasound)；\n* Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \\>150\u002F90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；\n* Known allergy to related drugs；\n* Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；\n* Pregnant and lactating women；\n* Those who tested positive for pregnancy before taking the drug after joining the trial；\n* Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；\n* Persons without personal freedom and independent capacity for civil conduct。","70 Years",{"count":84,"type":21},1406,[86],"PHASE3","compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients",[89],"HER2 Positive Early Breast Cancer","2023-06-23",{"date":92,"type":42},"2023-06-27",{"date":94,"type":42},"2023-06-07",{"date":96,"type":21},"2031-07-01",{"name":98,"class":49},"Fudan University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":74},"100420083","phase-1-neoadjuvant-therapy-study-guided-by-drug-screening-in-vitro-for-her2-positive-early-breast-cancer-patients-100420083","NCT04750122","Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients","Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients","Inclusion Criteria:\n\n* invasive breast cancer\n* HER2 positive\n* T2 or node positive\n* ECOG 0-1\n\nExclusion Criteria:\n\n* stage IV\n* inflammatory breast cancer\n* Severe chronic disease",{"count":107,"type":21},46,[109,24],"PHASE1","Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now.\n\nPreviously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a metheod for omitting chemotherapy for her2 positive participants.",[27],"2021-03-28",{"date":114,"type":42},"2021-04-01",{"date":112,"type":21},{"date":117,"type":21},"2026-12-31",{"name":119,"class":49},"Peking University People's Hospital","HER2-Positive Early Breast Cancer"]