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

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

doi:10.1038/s43856-026-01483-z

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

Commun Med (Lond). 2026 Mar 2;6(1):202. doi: 10.1038/s43856-026-01483-z.

Authors

Xiaolu Xu^#¹, Jincai Zhong^#², Hong Lin^#³, Hong Wang^#⁴, Jinhui Ye^#⁵, Caiwen Du⁶, Zhihui Wang⁷, Guorong Zou^{8

9}, Jie Ouyang¹⁰, Gengsheng Yu⁷, Yongxia Wang¹¹, Luzhen Li¹², Fei Xu¹³, Shien Cui¹⁴, Mei Xiao¹⁵, Peijian Peng¹⁶

Affiliations

¹ Department of Breast Disease, The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, P. R. China.
² Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical university, Naning, Guangxi, P. R. China.
³ Department of Breast Disease, Zhuhai Hospital of lntegrated Traditional Chinese and Western Medicine, Zhuhai, Guangdong, P. R. China.
⁴ Department of Breast Surgery, Zhuhai Maternity and Child Health Hospital, Zhuhai, Guangdong, P. R. China.
⁵ Department of Breast Internal Medicine, The First People's Hospital of Zhaoqing, Guangdong, P. R. China.
⁶ Department of Breast Disease, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Guangdong, P. R. China.
⁷ Department of Oncology, Jiangmen Central Hospital, Jiangmen, Guangdong, P. R. China.
⁸ Department of Oncology, Panyu central Hospital, Guangzhou, Guangdong, P. R. China.
⁹ Cancer Institute of Panyu, Guangzhou, Guangdong, P. R. China.
¹⁰ Department of Breast, Dongguan Tungwah Hospital, Dongguan, Guangdong, P. R. China.
¹¹ Department of Breast, Dongguan People's Hospital, Dongguan, Guangdong, P. R. China.
¹² Department of Oncology, Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine, Zhongshan, Guangdong, P. R. China.
¹³ Department of Medical Oncology, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, P. R. China.
¹⁴ Breast Center, Department of General Surgery, Zhongshan City People's Hospital, Zhongshan, Guangdong, P. R. China.
¹⁵ Department of Breast Disease, The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, P. R. China. xiaomei@mail.sysu.edu.cn.
¹⁶ Department of Breast Disease, The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, P. R. China. pengpj@mail.sysu.edu.cn.

^# Contributed equally.

Abstract

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.

Plain language summary

People with advanced breast cancer that is HER2-negative often run out of treatment options after their first therapy. A drug combination called eribulin and gemcitabine works well as an initial treatment, but we didn’t know if it could help later on. To find out, we ran a study in 13 hospitals in China with 70 patients. They received both drugs every three weeks, and we tracked how their cancer responded and what side effects they had. Almost half of the patients saw their tumours shrink, and most had their cancer under control for an average of about seven months. Side effects, mainly related to blood counts, were manageable. These results suggest this drug combination could give people with advanced breast cancer another effective option.