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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
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
Bicalutamide 150mg/day,every 28 days
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Clinical benefit rate for 16 weeks
The proportion of patients with complete response, partial response and stable disease
Time frame: 16 weeks
progression-free survival
Time frame: 24 months
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