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

NCT07321015 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-06

No results posted yet for this study

Summary

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 cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1/2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.

Conditions

  • Platinum-sensitive
  • TNBC, Triple Negative Breast Cancer
  • BRCA1/2 Mutation or Not

Interventions

DRUG

Fluzoparib Monotherapy

Fluzoparib is an oral poly (ADP-ribose) polymerase (PARP) inhibitor supplied as 50 mg capsules. Participants take 150 mg twice daily (total 300 mg/day) on days 1-28 of each 28-day cycle. Doses should be swallowed whole with water, approximately 12 hours apart, at approximately the same times each day. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Dose interruptions or reductions (stepwise to 100 mg BID or 50 mg BID) are allowed for haematological or non-haematological toxicities graded ≥3 or as clinically indicated. No concurrent anticancer therapy is permitted during fluzoparib maintenance.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321015 on ClinicalTrials.gov