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

Name: Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy — clinical trial record (NCT06957379)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 2

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Started2024-02-29

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.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

42 trials monitored

See 1 trial at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

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