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Study Description

This is a study to determine the efficacy of androgen receptor (AR) inhibitors in LAR (luminal androgen receptor)-enriched triple-negative breast cancer (TNBC) in the neoadjuvant setting. Twenty-four patients were treated with neoadjuvant AR inhibitor enzalutamide and paclitaxel for 12 weeks. Whole exome sequencing and RNA-sequencing was performed prior to treatment. The data for only two patients are consented for release through dbGaP. The remaining data are available under a Materials Transfer Agreement with the University of Texas MD Anderson Cancer Center.

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Study Inclusion/Exclusion Criteria

This study included patients with triple-negative breast cancer (TNBC) with the luminal androgen receptor (LAR) features that are deemed non-responsive to chemotherapy. TNBC was determined by <10% estrogen receptor and progesterone receptor staining, and HER2 immunohistochemistry score < 3 with no gene copy number amplification. To be included in this study, tumors must have at least 10% cells expressing nuclear androgen receptor by immunohistochemistry, however not mandated to have LAR phenotype determined by Vanderbilt sub typing. Non-response to chemotherapy was determined by a reduction in sonographic volume of less than 70% after four cycles of doxorubicin and cyclophosphamide.

Study History

The study was initiated in 2015.

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Study Attribution
  • Principal Investigators
    • Bora Lim. The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
    • Naoto T. Ueno. University of Hawaii Cancer Center, Honolulu, HI, USA.