NCT06929325View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2027

Conditions
HR+/HER2- Advanced/Metastatic Breast Cancer
Interventions
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

Trial Locations (1)

Unknown

Clinical Trials Information Group, Shijiazhuang

All Listed Sponsors
lead

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY