Enzalutamide for the treatment of androgen receptor-expressing triple-negative breast cancer Journal Article


Authors: Traina, T. A.; Miller, K.; Yardley, D. A.; Eakle, J.; Schwartzberg, L. S.; O'Shaughnessy, J.; Gradishar, W.; Schmid, P.; Winer, E.; Kelly, C.; Nanda, R.; Gucalp, A.; Awada, A.; Garcia-Estevez, L.; Trudeau, M. E.; Steinberg, J.; Uppal, H.; Tudor, I. C.; Peterson, A.; Cortes, J.
Article Title: Enzalutamide for the treatment of androgen receptor-expressing triple-negative breast cancer
Abstract: Purpose Studies suggest that a subset of patients with triple-negative breast cancer (TNBC) have tumors that express the androgen receptor (AR) and may benefit from an AR inhibitor. This phase II study evaluated the antitumor activity and safety of enzalutamide in patients with locally advanced or metastatic AR-positive TNBC. Patients and Methods Tumors were tested for AR with an immunohistochemistry assay optimized for breast cancer; nuclear AR staining . 0% was considered positive. Patients received enzalutamide 160 mg once per day until disease progression. The primary end point was clinical benefit rate (CBR) at 16 weeks. Secondary end points included CBR at 24 weeks, progression-free survival, and safety. End points were analyzed in all enrolled patients (the intent-to-treat [ITT] population) and in patients with one or more postbaseline assessment whose tumor expressed $ 10% nuclear AR (the evaluable subgroup). Results Of 118 patients enrolled, 78 were evaluable. CBR at 16 weeks was 25% (95% CI, 17% to 33%) in the ITT population and 33% (95% CI, 23% to 45%) in the evaluable subgroup. Median progression-free survival was 2.9 months (95% CI, 1.9 to 3.7 months) in the ITT population and 3.3 months (95% CI, 1.9 to 4.1 months) in the evaluable subgroup. Median overall survival was 12.7 months (95% CI, 8.5 months to not yet reached) in the ITT population and 17.6 months (95% CI, 11.6 months to not yet reached) in the evaluable subgroup. Fatigue was the only treatment-related grade 3 or higher adverse event with an incidence of . 2%. Conclusion Enzalutamide demonstrated clinical activity and was well tolerated in patients with advanced AR-positive TNBC. Adverse events related to enzalutamide were consistent with its known safety profile. This study supports additional development of enzalutamide in advanced TNBC. © 2018 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 36
Issue: 9
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2018-03-20
Start Page: 884
End Page: 890
Language: English
DOI: 10.1200/jco.2016.71.3495
PROVIDER: scopus
PMCID: PMC5858523
PUBMED: 29373071
DOI/URL:
Notes: Article -- Export Date: 1 May 2018 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Ayca Gucalp
    77 Gucalp
  2. Tiffany A Traina
    145 Traina