This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.
Triple-negative breast cancer (TNBC) is defined as the absence of estrogen and progesterone receptor expression as well as ERBB2 amplification. It has no response to endocrine or anti-ERBB2 therapies. Recent studies have found some potential therapeutic targets for TNBC. However, it still has a poor outcome. It was reported that TNBC has six subtypes, including 2 basal-like (BL1 and BL2), an immunomodulatory (IM), a mesenchymal (M), a mesenchymal stem-like (MSL), and a luminal androgen receptor (LAR) subtype. Different subtype may be sensitive to different treatment. Bicalutamide is an oral, non-steroidal, androgen receptor (AR) antagonist. It is approved by the Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Recently, a study explored the efficacy of bicalutamide in AR positive, estrogen receptor negative metastatic breast cancer (MBC), which showed a high clinical benefit rate (CBR) and a good safety profile. Based on the above reasons, we initiate this phase II study to evaluate the efficacy and safety of bicalutamide in AR positive metastatic triple-negative breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
150mg, po, qd, d1-28
Fudan University Shanghai Cancer Center
Shanghai, China
Clinical benefit rate (CBR)
Clinical benefit rate is defined as the percentage of patients who achieve complete response (CR), partial response (PR) and stable disease (SD) ≥24 weeks by RECIST version 1.1 criteria.
Time frame: every 8 weeks, up to 48 weeks
Objective response rate (ORR)
Objective response rate is defined as the percentage of patients who achieve complete response (CR) and partial response (PR) by RECIST version 1.1 criteria.
Time frame: every 8 weeks, up to 24 weeks
Progression free survival (PFS)
Progression free survival is defined as the time from enrollment to the first documented disease progression or death from any cause.
Time frame: every 8 weeks, up to 48 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluate incidence of adverse events and severity grade of these events
Time frame: every 4 weeks, up to 24 weeks
Overall Survival (OS)
Overall Survival is defined as the time from enrollment to death from any cause.
Time frame: every 3 months, up to 100 months
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