deltatrials
Not Yet Recruiting PHASE3 INTERVENTIONAL 2-arm 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.

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Conditions HR+/HER2- Advanced/Metastatic Breast Cancer
Interventions Fulvestrant Injection Placebo for Sirolimus for Injection (Albumin-bound) Sirolimus for Injection (Albumin-bound)
Updated 1 time since 2025 Last updated: Apr 14, 2025 Started: Apr 30, 2025 Primary completion: Oct 31, 2026 Completion: Dec 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates HR+/HER2- Advanced/Metastatic Breast Cancer and is currently actively recruiting participants. CSPC ZhongQi Pharmaceutical Technology Co., Ltd. leads this study, which shows 1 recorded version since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~May 2025 – present · 15 months · monthly snapshotNot Yet Recruiting

Change History

1 version recorded
Not Yet Recruiting — PHASE3 [monthly]

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Data source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations