NCT06957379

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

A Phase II Clinical Trial of the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for the Treatment of HR-positive, HER2-negative Patients With Advanced Breast Cancer Who Have Failed Standard Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase. This phase II trial enrolled patients with HR+/HER2- advanced breast cancer who had failed aromatase inhibitor (AI)/fulvestrant ± CDK4/6i. Pts failing prior AI ± CDK4/6i received nab-Sirolimus + fulvestrant, while those failing fulvestrant ± CDK4/6i received nab-Sirolimus + AI.

Conditions

• HR+/HER2- Advanced/Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Oral administration at a dose of 2.5 mg once daily for a 4-week cycle
DRUG	Anastrozole	Oral administration at a dose of 1 mg once daily for a 4-week cycle
DRUG	Exemestane	Oral administration at a dose of 25 mg once daily with a meal every 4 weeks
DRUG	Fulvestrant	Fulvestrant: 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	Sirolimus for Injection (Albumin-bound)	IV infusion, every 2 weeks, 4 weeks per treatment cycle

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: China