Clinical Trial

Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer

Active, Not Recruiting Phase 3
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Summary
This is a Phase III clinical trial for patients with a specific type of advanced breast cancer that is HER2-negative and has a biomarker called "Homologous Recombination Deficiency (HRD)-positive." The study aims to compare the effectiveness and safety of two treatment strategies: Experimental Group: Patients will first receive 6 cycles of standard chemotherapy or antibody-drug conjugate (ADC) therapy chosen by their doctor. After completing these 6 cycles, they will switch to a combination of two oral targeted drugs: Fluorizoparib and Apatinib, as long-term maintenance therapy. Control Group: Patients will continue to receive their doctor's choice of standard chemotherapy or ADC therapy without switching to the targeted drug combination. Patients will be randomly assigned (like flipping a coin) to one of the two groups.
Trial Details
NCT Number NCT07371910
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Metastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast Cancer
Enrollment 200 participants
Start Date 2024-06-12
Primary Completion 2031-03 (estimated)
Study Completion 2031-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-28