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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Docetaxel; Estradiol; Fulvestrant

Criteria

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