Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer

Study Overview
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Brief Summary
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Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast

Detailed Description
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This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).

Official Title
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A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer

Conditions
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Metastatic Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: TPC
* Drug: Bicalutamide 150 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70 years old, female Eastern Cooperative Oncology Group (ECOG) 0 or 1 Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis After Recurrence has not received cancer treatment Life expectancy of at least 6 months Signed and dated an informed consent form Exclusion Criteria: ECOG score ≧2 Only brain metastasis or meningeal metastasis Receiving other anti-tumor treatment Heart,lung,liver,kidney,bone marrow,and other functions badness

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TPC chemotherapy<br>Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin) | Drug: TPC<br>* Conventional chemotherapy(choose a): TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks. GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 & days 8)every 3 weeks. GC:(Gemcitabine 1000mg/m2 on days 1 & days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 & days 8) every 3 weeks<br>* Other names: Chemotherapy;|
| Experimental: Bicalutamide<br>Bicalutamide 150mg/day every 28 days | Drug: Bicalutamide 150 mg<br>* Bicalutamide 150mg/day,every 28 days<br>* Other names: Bicalutamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate for 16 weeks | The proportion of patients with complete response, partial response and stable disease | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 24 months |