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

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.

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Journal
Signal Transduction and Targeted Therapy
Published
2026-05-22
DOI
https://doi.org/10.1038/s41392-026-02720-6
Primary Topic
Cancer Treatment and Pharmacology
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Guorong Zou, 文远玉, Haizhu Chen, Linxiaoxiao Ding et al.
Signal Transduction and Targeted Therapy
Cancer Treatment and Pharmacology
article

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

Guorong Zou, 文远玉, Haizhu Chen, Linxiaoxiao Ding, Daren Lin, Ziliang Cheng, Zhiyong Wu, Yinduo Zeng, P. Peng, Zhongyu Yuan, Qianjun Chen, Ying Zhang, Liqun Zou, Caiwen Du, Ying Lin, Jinhui Ye, Quchang Ouyang, Jianli Zhao, Chengcai Yao, Yongkui Lu, Herui Yao, De Zeng, Kun Wang, Ling Li, Shusen Wang, Ying Wang, Hong Wang, Ying Lu, Wenjing Wu, Yunfang Yu, Jincai Zhong, Mei Huang, Yaping Yang
article en

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.

Signal Transduction and Targeted TherapyVol. 11(1)
Guangzhou University of Chinese Medicine (CN), Central South University (CN), Nanchang University (CN), Sun Yat-sen University (CN), Guangxi Medical University (CN), Guangdong Medical College (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Sichuan University (CN), West China Medical Center of Sichuan University (CN), Shantou University (CN), National Cancer Center (US), West China Hospital of Sichuan University (CN), Cancer Hospital of Shantou University Medical College (CN), Sixth Affiliated Hospital of Sun Yat-sen University (CN), Sun Yat-sen Memorial Hospital (CN), First Affiliated Hospital of Guangzhou University of Chinese Medicine (CN), Guangdong Provincial Hospital of Traditional Chinese Medicine (CN), Fifth Affiliated Hospital of Sun Yat-sen University (CN), Third Hospital of Nanchang (CN), Hunan Cancer Hospital (CN), Second Hospital of Nanchang (CN), Panyu District Central Hospital (CN), First Affiliated Hospital of GuangXi Medical University (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Fourth Affiliated Hospital of Guangxi Medical University (CN), Shantou Central Hospital (CN), Guangdong Academy of Medical Sciences (CN), Sun Yat-sen University Cancer Center (CN), Jiangmen Central Hospital (CN), The First People's Hospital of Zhaoqing (CN), Tumor Hospital of Guangxi Medical University (CN), Affiliated Hospital of Guangdong Medical College Hospital (CN), South China University of Technology (CN), Guangzhou Medical University (CN)
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
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Openalex Percentile: Top 8%
Cancer Treatment and Pharmacology
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