An open‐label phase II study: The efficiency and safety of anlotinib + eribulin in patients with HER2 ‐negative metastatic breast cancer

Abstract This research (NCT04624711) evaluated the efficacy and safety of eribulin plus anlotinib in patients with HER2‐negative metastatic breast cancer (mBC) and explored the potential synergistic benefits of this combination. A total of 70 women with HER2‐negative breast cancer who had previously undergone anthracycline‐ or taxane‐based therapies were enrolled. Hormone receptor‐positive patients had also received CDK4/6 (Cyclin‐dependent kinase 4/6) inhibitor‐based endocrine therapy. All patients were treated with eribulin mesylate (1.4 mg/m 2 , administered intravenously on days 1 and 8) and anlotinib (12 mg orally, once daily on days 1–14) in 21‐day cycles. The median progression‐free survival (mPFS) was 7.00 months, with an objective response rate (ORR) of 50.00% and a disease control rate (DCR) of 94.29%. Patients with fewer than two visceral metastases exhibited a significantly longer median PFS than those with multiple visceral metastases (8.93 months vs. 6.90 months, p = 0.0337). The most common treatment‐related adverse events (TRAEs) were neutropenia (67.14%) and leukopenia (68.57%), with 41.43% and 27.14% of patients experiencing grade 3/4 hematologic toxicities, respectively. These findings suggest that the combination of eribulin and anlotinib demonstrated encouraging efficacy and a manageable safety profile, offering a potential therapeutic option for patients with HER2‐negative mBC.