A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

Conditions

• Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Fluzoparib; Apatinib — DRUG
  Fluzoparib Orally twice daily; Apatinib Orally once daily
• Fluzoparib — DRUG
  Fluzoparib Orally twice daily
• Physician's choice chemotherapy — DRUG
  Investigators will declare one of the following regimens: Capecitabine Vinorelbine

Study Details

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Key Dates

Start date

Jul 13, 2020

Status verified

Mar 2020

Primary completion

Jun 30, 2022

Completion

Jun 30, 2025

Study Design

Enrollment

474 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead-in, Doublet Arm
  Fluzoparib+Apatinib
• Experimental: Single Arm
  Fluzoparib
• Active Comparator: Physician's choice chemotherapy
  Capecitabine or Vinorelbine

Primary Outcome Measure

(Safety Lead-in) dose limited toxicity (DLT) [ Time Frame: up to 21 days ]