NCT06941142

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

An Ib/III Study to Evaluate the Safety and Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 382 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Sirolimus (albumin - bound)	Dose escalation, intravenous infusion
DRUG	Palbociclib tablet	The dosage is 125 mg, orally once a day. Taken continuously for three weeks followed by a one - week break, with a treatment cycle of four weeks
DRUG	Fulvestrant injection	The dosage is 500 mg, intramuscular injection. It is given on the 1st and 15th days of the first cycle, with a treatment cycle of four weeks. After that, it is administered once every four weeks.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-10-01
• Completion: 2028-06-01
• First posted: 2025-04-23
• Last updated: 2025-04-23