NCT05296577

Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anlotinib and vinorelbine	anlotinib 12mg orally ,2 weeks on/1 week off ,Q3W; vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.
DRUG	Vinorelbine injection	vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-03-25
• Last updated: 2023-09-25

Locations

1 site across 1 country: China