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Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Trial

Clinical Trial Summary

Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer.

Clinical Trial Description

The main goal of this clinical trial is to compare in the efficacy of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer and evaluate the PCR DFS,OS and safety of the subjects. The main question it aims is comparing the efficacy and safety of first-line application of CDK4/6 inhibitors combined with initial endocrine therapy versus sequential endocrine therapy after chemotherapy induction therapy in HR+/HER2-advanced breast cancer with rapidly progressive disease. This study is planned to include 144 patients with HR+/HER2-advanced breast cancer with rapidly progressive disease between November 2023 and November 2025 who meet the entry criteria. A central dynamic randomisation system was used for 1:1 allocation to the repositories combined with NSAI treatment group and the physician's choice of chemotherapy sequential repositories combined with NSAI treatment group, with stratification factors including: level of HR expression, and presence of liver/lung metastases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06375707
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Yongmei Yin, Ph.D
Phone 025-68307102
Email ymyin@njmu.edu.cn
Status Recruiting
Phase Phase 2
Start date January 9, 2024
Completion date December 2025
View Details
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