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

Conditions

• Fludzoparib" and Anti-angiogenic
• HRD-positive/HER2-negative Advanced Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Fluzoparib — DRUG
  Fluzoparib capsules appropriate dose oral, each treatment cycle defined as 3 weeks (21 days).
• Apatinib Mesylate — DRUG
  Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).
• Capecitabine tablets — DRUG
  Capecitabine tablets, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
• Vinorelbine Tartrate Oral — DRUG
  For the first three courses: reasonable dosage with reference to guidelines. After 3 courses of medication, it is recommended to increase the dose of vinorelbine tartrate once a week. Each treatment cycle defined as 3 weeks (21 days).
• Eribulin mesylate injection — DRUG
  Eribulin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
• Gemcitabine Hydrochloride — DRUG
  Gemcitabine, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
• Paclitaxel-albumin — DRUG
  Paclitaxel-albumin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

Study Details

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.

Key Dates

Start date

Jun 12, 2024

Status verified

Aug 2025

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fluzoparib Combined With Apatinib
  Fluzoparib combined with Apatinib group: Fluzoparib capsules oral +Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).
• Active Comparator: Chemotherapy selected by the investigator
  Control group: Control group: patients receive oral Capecitabine tablets, Vinorelbine Tartrate Capsules, or use intravenous Paclitaxel for Injection (Albumin Bound), Gemcitabine Hydrochloride for Injection, or other drugs selected by the investigator.

Primary Outcome Measure

Progression Free Survival，PFS（Independent Review Committee） [ Time Frame: 2 years ]

Central Contacts

• Zhao Jianli
  86-20-34070870
  [email protected]