NCT06375707

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS	Docetaxel: 100mg/m2 IV every 21 days Paclitaxel: 175mg/m2 every 21 days, IV drip Vinorelbine: 25mg/ m2 on days 1 and 8 of each cycle, 1 cycle in 21 days, IV drip Capecitabine: 1000mg/m2, 2 times/d, 2 consecutive weeks of oral discontinuation for 1 week. Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole 1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral
DRUG	Ribociclib combined with NSAI±OFS	Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole 1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: China