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

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

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).

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