drugset / Trial / NCT06941142

A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

NCT06941142

Phase 1 Not yet recruiting 382 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Dose-escalation and dose-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with palbociclib and fulvestrant in this patient population.

Timeline

Start
2025-04-30
Primary completion
2027-10
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule Intravenous
Background Fulvestrant Small molecule 500 mg Intramuscular
Background Palbociclib Small molecule 125 mg Oral

Indications