Status:
NOT_YET_RECRUITING
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Chinese PLA General Hospital
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different horm...
Eligibility Criteria
Inclusion
- To be eligible to participate in this trial, an individual must meet ALL the following criteria:
- Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
- Female patients ≥ 18 years of age at the time of signing ICF.
- Breast Cancer Requirements:
- Histologically or cytologically confirmed HER2-positive(IHC 3+ or ISH+) unresectable locally advanced or metastatic breast cancer (Note: Patients eligible for curative-intent treatment are excluded).
- Documented hormone receptor (HR) status.
- No prior systemic anti-tumor therapy for recurrent/metastatic disease (≤1 line of endocrine therapy is permitted\*).
- For patients who received (neo)adjuvant therapy: \>12 months between the end of systemic treatment (excluding endocrine therapy) and recurrence/metastasis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate Organ Function.
- Pregnancy and Contraception: Women of childbearing potential (WOCBP) must agree to use highly effective contraception from screening until7 months after the last dose of study treatment and must refrain from breastfeeding.
Exclusion
- An individual who meets ANY of the following criteria will be excluded from participation in this trial:
- Known active CNS metastases not treated with surgery or radiotherapy, except for those who have achieved stable disease for ≥1 month after treatment and have discontinued corticosteroids for \>2 weeks.
- Received major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biologic therapy, or investigational drug therapy within 4 weeks prior to the first dose of study treatment.
- Previous treatment with antibody-drug conjugates containing exatecan derivative topoisomerase I inhibitors.
- Presence of clinically significant cardiovascular conditions, including:
- Severe/unstable angina
- Symptomatic congestive heart failure (NYHA class ≥II)
- Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- Myocardial infarction within 6 months before the first dose
- Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2031
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT07179939
Start Date
September 10 2025
End Date
December 30 2031
Last Update
September 18 2025
Active Locations (1)
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1
Fudan University
Shanghai, China