Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)

PHASE2RecruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

August 13, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Advanced Breast Cancer
Interventions
DRUG

Ribociclib combined with AI±OFS

Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.

DRUG

physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS

Docetaxel: 100mg/m2 IV drip every 21 days; Paclitaxel: 175mg/m2 every 21 days, IV drip; Paclitaxel for Injection (Albumin Bound): 100\~150mg/m2 IV drip every 7 days; 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; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.

Trial Locations (1)

Unknown

RECRUITING

Jiangsu Provincial People's Hospital, Nanjing

All Listed Sponsors
collaborator

Yidu Central Hospital of Weifang

UNKNOWN

collaborator

Affiliated Hospital of Jiangnan University

OTHER

collaborator

The Affiliated Jiangyin Hospital of Southeast University Medical College

UNKNOWN

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER