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

Study Overview
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Brief Summary
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Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

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

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel Plus Fulvestrant<br>Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later | Drug: Docetaxel<br>* 75mg/m2 D2 every 21 days<br>* Other names: Taxotere;Drug: Fulvestrant<br>* 500mg D1, D15, D29, D57, every 28 days later<br>* Other names: Faslodex;|
| Active Comparator: Docetaxel<br>Docetaxel:75mg/m2 D2 every 21 days | Drug: Docetaxel<br>* 75mg/m2 D2 every 21 days<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | 6 Weeks | 
| Overall Survival |  | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Endocrine therapy, Docetaxel, Fulvestrant