A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined ā¦ (NCT07290166) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined With CDK4/6 Inhibitors in Neoadjuvant Therapy for ER-positive HER2-positive Breast Cancer Patients.
42 participantsStarted 2025-12-31
Plain-language summary
To further enhance treatment efficacy, minimize reliance on chemotherapy, and identify the optimal neoadjuvant approach for ER-positive and HER2-positive population, we have designed a single-arm, phase II clinical trial. This study aims to evaluate the efficacy and safety of a novel regimen integrating CDK4/6 inhibitors intensified endocrine therapy and dual HER2-targeted monoclonal antibodies plus the tyrosine kinase inhibitor pyrotinib.
Who can participate
Age range18 Years ā 70 Years
SexFEMALE
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Inclusion criteria
ā. Women aged 18 to 70 years with breast cancer eligible for neoadjuvant therapy
ā. Clinically staged as II-III
ā. Histologically confirmed unilateral invasive breast cancer with HER2 positivity, defined as HER2 immunohistochemistry 3+ or in situ hybridization (FISH)-confirmed amplification
ā. Estrogen receptor (ER) expression ā„10% by immunohistochemistry
ā. Postmenopausal status
ā. Premenopausal or perimenopausal patients must undergo surgical oophorectomy or receive ovarian function suppression with gonadotropin-releasing hormone (GnRH) agonists
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
ā. Left ventricular ejection fraction (LVEF) ā„50% and corrected QT interval (QTc) ā¤470 ms
Exclusion criteria
ā. HER2-negative disease, defined as immunohistochemistry (IHC) score of 0 or 1+; or IHC 2+ without amplification by fluorescence in situ hybridization (FISH)
ā. Prior receipt of neoadjuvant therapy or any systemic or non-surgical local treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy
ā. History of another malignancy, except for adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ
. Inflammatory breast cancer, bilateral breast cancer, or presence of distant metastases
ā. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception during the study period
ā. Concurrent participation in another interventional clinical trial
ā. Significant organ dysfunction, including cardiac, pulmonary, hepatic, or renal impairment; left ventricular ejection fraction (LVEF) \<50% on echocardiography; history of major cardiovascular or cerebrovascular events within 6 months prior to enrollment (e.g., unstable angina, chronic heart failure, myocardial infarction, or stroke); uncontrolled hypertension (\>150/90 mmHg); or poorly controlled diabetes mellitus
ā. Current use of strong CYP3A4 inhibitors or inducers, including: