Spots Global Cancer Trial Database for Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

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Trial Identification

Brief Title: Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

Official Title: A Controlled, Phase II Study of Anlotinib vs Placebo Combination With Vinorelbine for the Treatment of HER2- Advanced Breast Cancer

Study ID: NCT05296577

Conditions

Breast Cancer

Interventions

anlotinib and vinorelbine

Vinorelbine injection

Study Description

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with vinorelbine in the treatment of HER2- advanced breast cancer.

Detailed Description: The eligible patients were HER2 negative advanced breast cancer patients who experienced failure of previous treatments with anthracyclines and/or taxanes , or hormone receptor-positive HER2-negative advanced breast cancer patients who progressed after at least first-line endocrine therapy in the advanced stage.The enrolled patients would receive anlotinib 12mg orally (2 weeks on/1 week off ,Q3W) plus vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle) or vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle).Imaging will be performed after the twice anlotinib administration as 2 cycles.This study is a randomized controlled, phase II clinical trial, and the treatment continued until radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.