Fulvestrant maintenance improves PFS versus capecitabine in HR+ HER2- metastatic breast cancer

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Signal transduction and targeted therapy Published May 22, 2026 Medically reviewed May 22, 2026 Study authors: Wu Wenjing, Yang Yaping, Chen Haizhu, Lu Yongkui, Zeng Yinduo, Zhao Jianli, Du Caiwen, Lin Ying, Pen… PubMed ↗ NCT04263298 ↗ DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider fulvestrant maintenance for HR+ HER2- metastatic breast cancer after first-line chemotherapy response, based on improved PFS.

This randomized phase 3 trial was conducted at 22 hospitals in mainland China. The population included 210 patients with hormone receptor-positive, HER2-negative metastatic breast cancer who had achieved an objective response or disease control following first-line chemotherapy.

Patients received fulvestrant as the intervention or capecitabine as the comparator. The primary outcome was investigator-assessed progression-free survival (PFS). The study had a median follow-up of 33.6 months (range 1.5-81.1).

Median PFS favored fulvestrant compared with capecitabine. The hazard ratio was 0.63 (95% CI 0.47-0.99; p = 0.003). Absolute numbers were 17.3 months for fulvestrant versus 9.0 months for capecitabine.

Safety was favorable. Grade >=3 adverse events occurred in 2.9% of patients on fulvestrant versus 10.5% on capecitabine. Discontinuations were 0% for fulvestrant versus 7.6% for capecitabine. Serious adverse events were not reported.

A key limitation is that overall survival data were not yet mature. Practice relevance is that fulvestrant maintenance therapy significantly improves PFS compared to capecitabine in this patient group, but the evidence is from a single trial.

Study Details

Study typeRct

Sample sizen = 210

EvidenceLevel 2

Follow-up33.6 mo

PublishedMay 2026

PMID42168151

TrialNCT04263298

View Original 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.