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ACTIVE NOT RECRUITING
NCT06957379
PHASE2

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

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase II Clinical Trial of the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for the Treatment of HR-positive, HER2-negative Patients With Advanced Breast Cancer Who Have Failed Standard Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-02-29

Completion Date

2025-12

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

DRUG

Letrozole

Oral administration at a dose of 2.5 mg once daily for a 4-week cycle

DRUG

Anastrozole

Oral administration at a dose of 1 mg once daily for a 4-week cycle

DRUG

Exemestane

Oral administration at a dose of 25 mg once daily with a meal every 4 weeks

DRUG

Fulvestrant

Fulvestrant: 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

Sirolimus for Injection (Albumin-bound)

IV infusion, every 2 weeks, 4 weeks per treatment cycle

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China