NCT06929325

Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors

A Randomized, Double-blind, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant Versus Placebo Combined With Fulvestrant in HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Patients After Prior CDK4/6 Inhibitor Treatment.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.

Conditions

• HR+/HER2- Advanced/Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Sirolimus for Injection (Albumin-bound)	IV infusion, every 2 weeks, 4 weeks per treatment cycle
DRUG	Fulvestrant Injection	IM injection, 500 mg, on day 1 and day 15 of Cycle 1, and then on day 1 of each cycle thereafter, 4 weeks per treatment cycle
DRUG	Placebo for Sirolimus for Injection (Albumin-bound)	IV infusion, every 2 weeks, 4 weeks per treatment cycle

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: China