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
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Maintenance therapy is key in prolonging remission and improving quality of life for hormone receptor-positive (HR + ), HER-2 negative (HER2-) metastatic breast cancer (MBC), but optimal strategies remain debated. This multicenter, open-label, randomized phase 3 trial conducted across 22 hospitals in mainland China (ClinicalTrials.gov, NCT04263298; Chinadrugtrials.org.cn, ChiCTR-IIR-17014036) compared the efficacy and safety of fulvestrant versus capecitabine as maintenance therapy in HR + /HER2- MBC patients after achieving objective response or disease control following first-line chemotherapy. The primary end point was investigator-assessed progression-free survival (PFS). A total of 210 patients underwent randomization, with 105 assigned to each group. As of the data cutoff date on March 1, 2025, the median follow-up was 33.6 months (range 1.5-81.1). 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). Overall survival data were not yet mature. Grade ≥3 adverse events (AEs) occurred in three patients (2.9%) in the fulvestrant group and 11 (10.5%) in the capecitabine group. Treatment discontinuation due to AEs occurred in 0% and 7.6% of patients, respectively. Fulvestrant maintenance therapy significantly improves PFS compared to capecitabine in HR + /HER2- MBC patients achieving objective response or disease control following first-line chemotherapy, with a favorable safety profile.
Authors: Wenjing Wu, Yaping Yang, Haizhu Chen, Yongkui Lu, Yinduo Zeng, Jianli Zhao, Caiwen Du, Ying Lin, Peijian Peng, Mei Huang, Ying Zhang, Quchang Ouyang, Linxiaoxiao Ding, Ziliang Cheng, Yuanyu Wen, Zhiyong Wu, Jinhui Ye, Li Ling, Kun Wang, Ying Lu, Guorong Zou, Jincai Zhong, Hong Wang, Daren Lin, De Zeng, Chengcai Yao, Qianjun Chen, Liqun Zou, Shusen Wang, Yunfang Yu, Zhongyu Yuan, Ying Wang, Herui Yao
Institutions: Sun Yat-sen University, Sun Yat-sen Memorial Hospital, Guangxi Medical University, Fourth Affiliated Hospital of Guangxi Medical University, Tumor Hospital of Guangxi Medical University, Chinese Academy of Medical Sciences & Peking Union Medical College, The First Affiliated Hospital, Sun Yat-sen University, Fifth Affiliated Hospital of Sun Yat-sen University, Guangzhou University of Chinese Medicine, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Medical College, Central South University, Hunan Cancer Hospital, Shantou Central Hospital, The First People's Hospital of Zhaoqing, Guangdong Academy of Medical Sciences, Guangdong Provincial People's Hospital, Southern Medical University, Panyu District Central Hospital, Guangzhou Medical University, First Affiliated Hospital of GuangXi Medical University, Jiangmen Central Hospital, Cancer Hospital of Shantou University Medical College, Shantou University Medical College, South China University of Technology, Guangdong Provincial Hospital of Chinese Medicine, Sichuan University, West China Medical Center of Sichuan University, West China Hospital of Sichuan University, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,790
Funders: Beijing Xisike Clinical Oncology Research Foundation, National Natural Science Foundation of China, Sun Yat-sen University, State Key Laboratory of Oncology in South China, National Science and Technology Major Project, Science and Technology Planning Project of Guangdong Province, Sun Yat-sen University Cancer Center, Basic and Applied Basic Research Foundation of Guangdong Province
OpenAlex ID: W7161966264