NCT07061717View on ClinicalTrials.gov

Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

474

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2029

Study Completion Date

July 1, 2029

Conditions
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Interventions
DRUG

Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd

Standard-Dose Palbociclib + Endocrine therapy

DRUG

Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid

Standard-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine

DRUG

Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid

High-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine

Trial Locations (1)

Unknown

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER