NCT06015126

Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yan Xue · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has been the subject of several clinical studies, with proven effectiveness and good safety, showing great prospects for application. Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for the treatment of HER2-negative advanced breast cancer.

Detailed description

Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer. Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib: 12mg/capsule, 10mg/capsule, 8mg/capsule Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer, and to provide new data for later-line treatment of HER2-negative advanced breast cancer. Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 60 patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	metronomic oral vinorelbine plus anlotinib	To clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer

Timeline

• Start date: 2022-10-05
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: China