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

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/m², 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.