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Background <p>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.</p> Methods <p>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/m<sup>2</sup>) and gemcitabine (1.0 g/m<sup>2</sup>) 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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月2日

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

摘要

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.