ArticleTranslational breast cancer research : a journal focusing on translational research in breast cancer2026
The efficacy and safety of metronomic vinorelbine combined with anlotinib in HER2-negative advanced breast cancer: a prospective, single-arm clinical study.
Article in Translational breast cancer research : a journal focusing on translational research in breast cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: In the era of chronic cancer management, second-line treatment for HER2-negative (HER2-) advanced breast cancer demands convenient and safe therapeutic options. Vinorelbine tartrate soft capsules are an oral chemotherapeutic agent, and anlotinib is an oral multi-target anti-angiogenic drug. The aim of this study is to investigate the efficacy and safety of metronomic vinorelbine combined with anlotinib in HER2- advanced breast cancer. Methods: This is a prospective, single-arm, single center clinical study. Women with metastatic HER- breast cancer who had received one prior line of endocrine ± targeted therapy or chemotherapy ± immunotherapy were enrolled. Treatment consisted of vinorelbine tartrate soft capsules 30-50 mg orally three times weekly (every other day) plus anlotinib 12 mg once daily on days 1-14 of each 21-day cycle. The primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Results: Fifty-eight patients were enrolled. ORR was 63.8% and DCR 89.7%. Median PFS (mPFS) was 7.0 months [95% confidence interval (CI): 6.4-7.8]. Subgroup analyses showed that patients with prior PFS ≥6 months or Ki-67 ≤20% derived greater benefit: mPFS 7.5 Conclusions: Metronomic vinorelbine plus anlotinib shows favorable efficacy in HER2- advanced breast cancer without increasing the risk of AEs.
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