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

Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
Study ID
NCT07684456
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Utidelone Capsule — DRUG
    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.
  • Utidelone Injection — DRUG
    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.
  • Capecitabine — DRUG
    Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.

Study Details

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.

Key Dates

First listed
Jul 6, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Utidelone Capsule combined with Capecitabine
  • Active Comparator: Utidelone Injection combined with Capecitabine

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 6 weeks ]

Central Contacts

Related Studies