Clinical Trial

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

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated May 4, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06957379
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions HR+/HER2- Advanced/Metastatic Breast Cancer
Enrollment 78 participants
Start Date 2024-02-29
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-04