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

PHASE2RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

January 9, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Advanced Breast Cancer
Interventions
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

Trial Locations (1)

210000

RECRUITING

Jiangsu Provincial People's Hospital, Nanjing

All Listed Sponsors
collaborator

Zhejiang Cancer Hospital

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER