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Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

StatusRecruiting
PhasePhase 3
Started2024-06-12
View on ClinicalTrials.gov ↗

Amendment history

2025-08-12
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02→confirmed 2024-06-12
Eligibility criteria+924 characters
Inclusion Criteria:criteria Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging; Pathological diagnosis of HER-2 was negative (definition: immunohistochemical results were 0、+ or ++ and in situ hybridization results were negative); Patient tested positive for HRD (defined by: [...] The subjects must meet all of the following conditions: Adult female patients (aged 18 to 70 years) with metastatic breast cancer diagnosed by pathology or imaging; 2) Pathological confirmation of HER2 negative (definition: immunohistochemical result is 0 or + or ++ and i [...] [...]
Study sitesdetails revised at 1 of 1 site
2024-02-05
Original filing
This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets. The trial aims at extending the combination target therapy involving PARP inhibitors and anti-angiogenesis from only BRCA mutation carriers to all patients with homologous recombination repair defects (HRD-positive). The phase III randomized clinical study will investigate the effectiveness of the combination therapy of PARP inhibitor "fludzoparib" and anti-angiogenic "apatinib" in treating HRD-positive/HER2-negative advanced breast cancers.
Trial Details
NCT Number NCT06255392
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Fludzoparib" and Anti-angiogenic, 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 2025-08-15