It is a phase III trial to explore the efficacy and safety of utidelone plus capecitabine versus taxane plus capecitabine in HER2-negative locally advanced or metastatic breast cancer and the differences of metronomic capecitabine and intermittent capecitabine in combination chemotherapy.
Signed Informed Consent Form;
Women aged ≥ 18 years;
Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;
The primary tumor and metastases (if aspirated) are both HER2-negative;
HER-2 positive (IHC + + +, or FISH positive);
Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;
Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;
Sun Yat-sen University
Lead sponsor
Chengdu Biostar Pharmaceuticals
Collaborator