Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

Summary

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.

Timeline

Start

2018-05-01

Primary completion

2025-05-01

Completion

2030-05-01

Outcome

Met primary endpoint

paper Median PFS favored fulvestrant compared with capecitabine (17.3 months [95% CI 12.7-23.3] vs. 9.0 months [95% CI 7.5-14.3]; hazard ratio 0.63, 95% CI 0.47-0.99; p = 0.003). PMID 42168151 ↗

Publications

• Wu W, Yang Y, Chen H, Lu Y, Zeng Y, Zhao J, Du C, Lin Y, Peng P, Huang M, Zhang Y, Ouyang Q, Ding L, Cheng Z, Wen Y, Wu Z, Ye J, Ling L, Wang K, Lu Y, Zou G, Zhong J, Wang H, Lin D, Zeng D, Yao C, Chen Q, Zou L, Wang S, Yu Y, Yuan Z, Wang Y, Yao H. Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial. Signal Transduct Target Ther. 2026 May 22;11(1):191. doi: 10.1038/s41392-026-02720-6.

Drugs

Indications