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.

Trial Details

NCT ID
NCT06255392
Phase
PHASE3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Fluzoparib
  • Apatinib Mesylate
  • Capecitabine tablets
  • Vinorelbine Tartrate Oral
  • Eribulin mesylate injection
  • Gemcitabine Hydrochloride
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • 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 n…
  • 10\) Adequate bone marrow functional reserve:
  • White blood cell count (WBC) ≥3.0×10\^9 / L

For full eligibility, visit ClinicalTrials.gov.

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