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

Not Applicable

Not yet recruiting

• 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; 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; 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

• Registration Number: NCT07061717
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This is a a phase III, randomized, open-label clinical trial 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 474

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group1	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
Experimental Group 1	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
Experimental Group 2	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

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) as Assessed by the Investigator	3 years after random assignment

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)	3 years after random assignment
Overall Survival (OS)	3 years after random assignment
Objective Response Rate (ORR)	3 years after random assignment
Clinical Benefit Rate (CBR)	6 months after random assignment
Treatment Associated Adverse Effect	3 years after random assignment
Patient-Reported Outcomes (PRO)	3 years after random assignment

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China