A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Dose-escalation and dose-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with palbociclib and fulvestrant in this patient population.

NCT Number	NCT06941142
Lead Sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions	Advanced Breast Cancer
Enrollment	382 participants
Start Date	2025-04-30
Primary Completion	2027-10 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2025-04-23