A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance

Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1/2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian

Trial Details

NCT ID
NCT07321015
Phase
PHASE2
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Fluzoparib Monotherapy
Locations (sample)
  • Tianjin, China|39.14222,117.17667

Key Eligibility Criteria

  • Age 18-75 years (inclusive) at the time of informed consent.
  • Histologically confirmed triple-negative breast cancer (TNBC; ER \<1%, PR \<1%, HER2-negative).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Received ≥2 prior lines of systemic therapy, including a platinum-based regimen (single-agent or combination); must have achieved partial response …

For full eligibility, visit ClinicalTrials.gov.

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