drugset / Trial / NCT07061717

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

NCT07061717

Phase 3 Not yet recruiting 474 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2029-07-01
Completion
2029-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 600 mg
Comparator Palbociclib Small molecule 125 mg
Comparator Palbociclib Small molecule 200 mg
Comparator Anastrozole Other / unclassified 1 mg
Comparator Exemestane Small molecule 25 mg
Comparator Letrozole Other / unclassified 2.5 mg