Fulvestrant maintenance improves PFS versus capecitabine in HR+ HER2- metastatic breast cancerFulvestrant maintenance therapy significantly improves progression free survival compared to capecitabine in hormone receptor positive metastatic breast cancer patients

Signal transduction and targeted therapy Published 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 ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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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.

A medical trial looked at how two different drugs work for a specific type of breast cancer. The study included 210 patients from hospitals across mainland China. These patients had cancer that had spread and had already received one round of chemotherapy.

After the first treatment, doctors gave patients either fulvestrant or capecitabine. The main goal was to see how long it took for the cancer to start growing again. Patients taking fulvestrant stayed in remission for about 17 months. Those taking capecitabine had a shorter time before the cancer grew, around 9 months.

The drug called fulvestrant also caused fewer severe side effects. Only about 3% of patients had serious problems while taking it. In contrast, over 10% of patients on capecitabine had serious issues. No one had to stop taking fulvestrant because of bad reactions.

Although the study did not yet have full data on how long patients lived overall, the results are very promising. Fulvestrant offers a safer and more effective option for keeping cancer under control after the first treatment.

What this means for you:

Fulvestrant keeps hormone receptor positive metastatic breast cancer under control longer and with fewer side effects than capecitabine.

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.

Fulvestrant maintenance improves PFS versus capecitabine in HR+ HER2- metastatic breast cancerFulvestrant maintenance therapy significantly improves progression free survival compared to capecitabine in hormone receptor positive metastatic breast cancer patients

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