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Multicenter Study
. 2022 Oct;195(3):341-351.
doi: 10.1007/s10549-022-06669-2. Epub 2022 Aug 20.

Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: a feasibility study

Elaine M Walsh #  1 , Ayca Gucalp #  2 , Sujata Patil  3 , Marcia Edelweiss  4 , Dara S Ross  4 , Pedram Razavi  2 , Shanu Modi  2 , Neil M Iyengar  2 , Rachel Sanford  2 , Tiffany Troso-Sandoval  2 , Mila Gorsky  2 , Jacqueline Bromberg  2 , Pamela Drullinsky  2 , Diana Lake  2 , Serena Wong  2 , Patricia Ann DeFusco  5 , Nicholas Lamparella  6 , Ranja Gupta  6 , Tasmila Tabassum  2 , Leigh Ann Boyle  2 , Artavazd Arumov  2 , Tiffany A Traina  2
Affiliations
Multicenter Study

Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: a feasibility study

Elaine M Walsh et al. Breast Cancer Res Treat. 2022 Oct.

Abstract

Purpose: Chemotherapy with or without immunotherapy remains the mainstay of treatment for triple-negative breast cancer (TNBC). A subset of TNBCs express the androgen receptor (AR), representing a potential new therapeutic target. This study assessed the feasibility of adjuvant enzalutamide, an AR antagonist, in early-stage, AR-positive (AR +) TNBC.

Methods: This study was a single-arm, open-label, multicenter trial in which patients with stage I-III, AR ≥ 1% TNBC who had completed standard-of-care therapy were treated with enzalutamide 160 mg/day orally for 1 year. The primary objective of this study was to evaluate the feasibility of 1 year of adjuvant enzalutamide, defined as the treatment discontinuation rate of enzalutamide due to toxicity, withdrawal of consent, or other events related to tolerability. Secondary endpoints included disease-free survival (DFS), overall survival (OS), safety, and genomic features of recurrent tumors.

Results: Fifty patients were enrolled in this study. Thirty-five patients completed 1 year of therapy, thereby meeting the prespecified trial endpoint for feasibility. Thirty-two patients elected to continue with an optional second year of treatment. Grade ≥ 3 treatment-related adverse events were uncommon. The 1-year, 2-year, and 3-year DFS were 94%, 92% , and 80%, respectively. Median OS has not been reached.

Conclusion: This clinical trial demonstrates that adjuvant enzalutamide is a feasible and well-tolerated regimen in patients with an early-stage AR + TNBC. Randomized trials in the metastatic setting may inform patient selection through biomarker development; longer follow-up is needed to determine the effect of anti-androgens on DFS and OS in this patient population.

Keywords: Androgen-dependent breast cancer; Androgen-receptor positive; Anti-androgen therapy.

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Conflict of interest statement

Competing Interests

declare they have no financial interests.

Figures

Fig 1
Fig 1. CONSORT Diagram
Fig 2
Fig 2. Disease-free survival (gray shading indicates 95% confidence intervals)
Fig 3
Fig 3. Oncoprint showing genomic features of primary and recurrent tumors
See this image and copyright information in PMC

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