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

NCT07684456 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Beijing Biostar Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-03-01
Completion
2029-03-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684456 on ClinicalTrials.gov