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Communications medicine · 2026

Efficacy and safety of eribulin plus gemcitabine as second-line treatment for recurrent HER2-negative breast cancer: a phase II, single-arm, open-label trial.

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Xu Xiaolu, Zhong Jincai, Lin Hong, Wang Hong, Ye Jinhui, Du Caiwen, Wang Zhihui, Zou Guorong, Ouyang Jie, Yu Gengsheng, Wang Yongxia, Li Luzhen, Xu Fei, Cui Shien, Xiao Mei, Peng Peijian

Аннотация

BACKGROUND: Eribulin plus gemcitabine improves progression-free survival in chemotherapy-naive metastatic breast cancer patients, but its efficacy in second-line or later treatment remains unclear.

METHODS: This single-arm, phase II study was conducted at 13 Chinese medical centers. Eligible patients had histologically confirmed human epidermal growth factor receptor 2 negative metastatic breast cancer and had received at least one prior taxane-containing chemotherapy regimen and anthracycline-containing regimens in the adjuvant setting. Patients received intravenous infusions of eribulin (1.4 mg/m2) and gemcitabine (1.0 g/m2) on days 1 and 8 of a 21-day cycle. Progression-free survival, objective response rate and disease control rate were assessed. Adverse events were also recorded.

RESULTS: Here we show 70 patients took part in this study (71.4% hormone receptor positive/HER2 negative). Patients had received a median of three prior lines of systemic treatment. Overall, 48.6% have significant tumor shrinkage, 92.9% have tumor control, and median time without disease progression is 7.2 months (95% confidence interval, 5.5-10.9). Median time without disease progression is 8.4 months (hormone receptor positive) vs. 6.3 months (triple-negative, p = 0.1849). Grade 3-4 side effects mostly affect blood cells and are manageable.

CONCLUSIONS: Eribulin plus gemcitabine is effective and well-tolerated in patients with HER2-negative metastatic breast cancer needing second-line or later treatment, providing a valuable treatment option.