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