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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
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.
Details
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 200 |
| Start date | 2024-06-12 |
| Completion | 2031-03 |
Conditions
- Fludzoparib" and Anti-angiogenic
- HRD-positive/HER2-negative Advanced Breast Cancer
Interventions
- Fluzoparib
- Apatinib Mesylate
- Capecitabine tablets
- Vinorelbine Tartrate Oral
- Eribulin mesylate injection
- Gemcitabine Hydrochloride
- Paclitaxel-albumin
Primary outcomes
- Progression Free Survival，PFS（Independent Review Committee） — 2 years
The time from the beginning of treatment to the progression or death of the patient
Countries
China