Clinical Trial

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

Not Yet Recruiting Phase 2
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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 hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Trial Details
NCT Number NCT07179939
Lead Sponsor Fudan University
Collaborators: Jiangsu HengRui Medicine Co., Ltd., Chinese PLA General Hospital
Conditions HER2-positive Breast Cancer
Enrollment 288 participants
Start Date 2025-09-10
Primary Completion 2030-12-30 (estimated)
Study Completion 2031-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-18