A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer

A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Inclusion Criteria:

• Postmenopausal female between 18 and 70 years old
• ECOG performance status of ≤ 1
• Life expectancy more than 3 months
• Histologically confirmed metastatic breast cancer
• ER and&or PR pqositive, HER2-negative
• Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
• No pretreated chemotherapy for metastatic disease
• Have at least one target lesion according to RECIST 1.1
• No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
• Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>50ml/min

Exclusion Criteria:

• Pregnant or lactating women
• Evidence of CNS metastasis
• Seriously uncontrolled infection
• History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pretreated with Fulvestrant
• Pretreated with two or more lines of endocrine therapy