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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPC chemotherapy | Active Comparator | Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin) |
|
| Bicalutamide | Experimental | Bicalutamide 150mg/day every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPC | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate for 16 weeks | The proportion of patients with complete response, partial response and stable disease | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhong-Yu Yuan, M.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Sun Yat-sen University, Cancer Center |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
|
| Bicalutamide 150 mg | Drug | Bicalutamide 150mg/day,every 28 days |
|
|
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |