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

• Status: Terminated
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Bicalutamide; Gemcitabine

Criteria

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