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NOT YET RECRUITING
NCT07684456
PHASE3

Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.

Official title: A Randomized,Controlled Phase III Study on Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2026-08-01

Completion Date

2029-03-01

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

Utidelone Capsule

Utidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

DRUG

Utidelone Injection

Utidelone Injection:30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

DRUG

Capecitabine

Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China