Breast Neoplasms Clinical Trial
Official title:
Bicalutamide in Treating Patients With AR-positive Metastatic Triple Negative Breast Cancer
Growing studies demonstrated that Androgen Receptor (AR) has an oncogenic role for the patients with AR-positive Triple Negative Breast Cancer (TNBC). AR antagonists in therapy, such as bicalutamide, completely binds to the AR, increasing AR degradation, thus are investigated for the efficacy of the treatment of patients with AR-positive TNBC in the study.
More than 70% of human breast cancers express the androgen receptor (AR), and in
retrospective analysis, the expression of AR in Triple-Negative Breast Cancer (TNBC) varies
from 10-43%. Recently emerging preclinical and clinical data suggest that AR may play a role
in tumor proliferation. For example, Hu et al (2011) analyzed AR expression in 211 TNBC
cases. He found that AR is related with an 83% increase in overall mortality, when compared
with AR-negative TNBC. McGhan et al (2014) also found that AR expression tends to exist in
TNBC patients with higher tumor stage and lymph metastases.
The role of AR has also been extensively studied in vitro. With targeting AR with small
interfering RNA (siRNA) and treatment with anti-androgen bicalutamide, studies showed that
AR has a proliferative role in TNBC cells. Robinson et al (2011) also clarified that AR can
mimic estrogen receptor α (ERα) in a transcriptionally active manner directed by the
forkhead box protein A1 (FoxA1). These indicate that, in ER-negative disease, AR can promote
tumor progression, therefore, could serve as a therapeutic target in TNBC.
Due to the demonstration of oncogenic role for the AR in TNBC, clinical trials are underway
to study the role of inhibiting androgen signaling for the treatment for TNBC. For example,
Gucalp et al (2013) performed a sing-arm phase II study to investigate the role of
bicalutamide in AR-positive TNBC. A total of 26 patients were enrolled in the study, and the
study demonstrated a general well tolerated effect and a 6-month clinical benefit rate of
19%. Furthermore, future clinical trials are also designed to show the anti-androgen therapy
such as Enzalutamide, the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate
and orteronel for AR-positive TNBC. This study is investigated to study the role of
bicalutamide for AR-positive TNBC, and it may help clarify the effect of bicalutamide for
the specific breast cancer subtype. Furthermore, it may provide an additional therapy to
treat the difficult to treat population.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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