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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biostar Pharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form.

Subjects aged ≥18 and ≤75.

Male or female subjects with ECOG performance status scored 0-1.

Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology.

Disqualifiers

Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration.

Patients who have used Capecitabine or Utidelone within 6 months prior to randomization.

Patients with breast cancer with CNS metastases leptomeningeal metastases.

Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions.

Trial design

Treatments tested in this trial

  • Utidelone Capsule
  • Utidelone Injection
  • Capecitabine

Treatment groups

308 Participants
are divided into 2 treatment groups