Study Shows Fuzuloparib ± Apatinib Improves Progression-Free Survival in BRCA+ HER2– Metastatic Breast Cancer

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According to data presented during the ESMO Virtual Plenary in May 2024, a phase 3 study (NCT04296370) revealed that Fuzuloparib with or without apatinib offers a significant progression-free survival (PFS) benefit compared to standard chemotherapy in HER2-negative metastatic breast cancer patients with germline BRCA1/2 mutations.

Results showed that the combination of fuzuloparib plus apatinib led to a median PFS of 11.0 months compared to 3.0 months with standard chemotherapy. Single-agent fuzuloparib also showed a longer median PFS of 6.7 months versus 3.0 months with chemotherapy.

Lead researcher Huiping Li from Peking University Cancer Hospital and Institute in Beijing, China, stated that the study achieved its primary objectives by demonstrating the efficacy of fuzuloparib plus apatinib or fuzuloparib alone in this patient population.

The study enrolled patients with HER2-negative breast cancer and confirmed BRCA1/2 mutations who had previous exposure to certain treatments and specific disease characteristics. Patients were randomized to receive different treatment regimens based on fuzuloparib, apatinib, or chemotherapy.

Key secondary objectives were also met, showing that fuzuloparib monotherapy significantly improved PFS compared to chemotherapy. The study also assessed various secondary endpoints including overall survival, objective response rate, and safety.

Overall, the data suggested that fuzuloparib plus apatinib or fuzuloparib alone could be beneficial for patients with HER2-negative metastatic breast cancer and BRCA gene mutations.

Further research revealed trends indicating improved overall survival with the study drugs compared to standard chemotherapy. The treatment regimens also showed favorable objective response rates, disease control rates, and duration of response.

The safety profile of fuzuloparib and apatinib was consistent with previous reports, although some patients experienced treatment-related adverse effects requiring dose adjustments or discontinuation.

Dr. Li disclosed no conflicts of interest related to the study.


Li H, Liu J, Liu Y, et al. Fuzuloparib with or without apatinib in HER2- metastatic breast cancer (mBC) patients (pts) with germline BRCA1/2 mutations (gBRCA1/2m): a randomized phase III trial. Presented at the 2024 ESMO Virtual Plenary Session; May 9, 2024. Accessed May 9, 2024.

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