NCT04296370

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

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib±Apatinib Versus Physicians Choice Chemotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2020-07-13
• Primary completion: 2022-06-30
• Completion: 2025-06-30
• First posted: 2020-03-05
• Last updated: 2020-08-10

Locations

1 site across 1 country: China