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

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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.

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Data availability

The datasets generated during and/or analyzed during the current study are not publicly available as further follow-up, correlative work and analyses are ongoing but are available from the corresponding author on reasonable request.

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Funding

This study was supported in part through National Institutes of Health/National Cancer Institute Cancer Center Support Grant (P30 CA008748). Funding and drug support were provided by Astellas Pharma, Global Development, Inc/Pfizer Inc.

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Author notes

  1. Elaine M. Walsh, Ayca Gucalp are co-first authors.

Authors and Affiliations

  1. Department of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Center, 300 East 66thStreet, New York, NY, USA

    Elaine M. Walsh, Ayca Gucalp, Pedram Razavi, Shanu Modi, Neil M. Iyengar, Rachel Sanford, Tiffany Troso-Sandoval, Mila Gorsky, Jacqueline Bromberg, Pamela Drullinsky, Diana Lake, Serena Wong, Tasmila Tabassum, Leigh Ann Boyle, Artavazd Arumov & Tiffany A. Traina

  2. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Sujata Patil

  3. Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Marcia Edelweiss & Dara S. Ross

  4. Hartford Health Care Cancer Institute, Avon, CT, USA

    Patricia Ann DeFusco

  5. Lehigh Valley Health Network Cancer Institute, Allentown, PA, USA

    Nicholas Lamparella & Ranja Gupta

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  1. Elaine M. Walsh
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Correspondence to Elaine M. Walsh.

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Conflict of interest

A.G. reports research funding from Pfizer, Innocrin Pharma, Merck, Novartis, Roche, Oncotherapy, BioAtla, Zenith Epigenetics, and Bristol-Myers Squibb paid to the institution. P.R. reports receiving institutional grant/funding from Grail/Illumina, Novartis, AstraZeneca, Epic Sciences, Invitae/ArcherDx, Tempus, Inivata, Biothernostics; Consultation/Ad board/Honoraria from Novartis, Foundation Medicine, AstraZeneca, Pfizer, Daiichi, Epic Sciences, Inivata, Natera, Biovica, and Tempus. S.M. reports speaking/honoraria and research funds from Astrazeneca, Daiichi Sankyo, Seagen, Genetech, and Macrogenics. N.M.I. reports research grants (to institution) from National Cancer Society, American Cancer Society, Breast Cancer Research Foundation, and Novartis; consulting fees from Novartis and Seattle Genetics. E.M.W., S.P., M.E., D.S.R., R.S., T. T-S., M.G., J.B., P.D., D.L., S.W., P.A.D., N.L., R.G., T.T., L.A.B., A.A., and T.A.T. declare they have no financial interests.

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Walsh, E.M., Gucalp, A., Patil, S. et al. Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: a feasibility study. Breast Cancer Res Treat 195, 341–351 (2022). https://doi.org/10.1007/s10549-022-06669-2

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