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

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.

Timeline

Start

2020-07-13

Primary completion

2022-06-30

Completion

2025-06-30

Publications

• Li H, Liu J, Ouyang Q, Wang S, Liu Y, Teng Y, Wang X, Cheng J, Tong Z, Sun T, Yan M, Zhou X, Li F, Nie J, Shao ZM, Ye C, Wang Y, Wu X, Li Z, Wu Y, Xiong H, Li H, Gan L, Niu Z, Zhang J, Zhang Q, Pan Y, Wu X, Zhang Y, Xie W, Xiao Y, Gao J, Zhao H, Yin Y, Qian Z, Sun S, Zhang H, Wang K, Lu J, Li Y, Wang X, Yang X, Wang Y, Wang Q, Song E. Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1563-1574. doi: 10.1016/S1470-2045(25)00523-6.

Drugs

Indications