A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Chemotherapy, Endocrine therapy, Docetaxel, Fulvestrant
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel Type: Drug
Name: Fulvestrant Type: Drug
Overall Status
Recruiting
Summary
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
Detailed Description
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Fudan University Cancer Hospital
Shanghai, China
Status: Recruiting
Contact: Xichun Hu, MD,PhD - 64175590 - huxicun@gmail.com
Start Date
April 2014
Completion Date
April 2017
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page