Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: A feasibility study Journal Article
| Authors: | Walsh, E. M.; Gucalp, A.; Patil, S.; Edelweiss, M.; Ross, D. S.; Razavi, P.; Modi, S.; Iyengar, N. M.; Sanford, R.; Troso-Sandoval, T.; Gorsky, M.; Bromberg, J.; Drullinsky, P.; Lake, D.; Wong, S.; DeFusco, P. A.; Lamparella, N.; Gupta, R.; Tabassum, T.; Boyle, L. A.; Arumov, A.; Traina, T. A. |
| Article Title: | Adjuvant enzalutamide for the treatment of early-stage androgen-receptor positive, triple-negative breast cancer: A feasibility study |
| 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. © 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
| Keywords: | genetics; clinical trial; neoplasm recurrence, local; pathology; feasibility study; feasibility studies; multicenter study; tumor recurrence; androgen receptor; receptors, androgen; drug therapy; nitriles; nitrile; phenylthiohydantoin; benzamide derivative; benzamides; triple negative breast cancer; enzalutamide; humans; human; triple negative breast neoplasms; androgen-dependent breast cancer; androgen-receptor positive; anti-androgen therapy |
| Journal Title: | Breast Cancer Research and Treatment |
| Volume: | 195 |
| Issue: | 3 |
| ISSN: | 0167-6806 |
| Publisher: | Springer |
| Date Published: | 2022-10-01 |
| Start Page: | 341 |
| End Page: | 351 |
| Language: | English |
| DOI: | 10.1007/s10549-022-06669-2 |
| PUBMED: | 35986801 |
| PROVIDER: | scopus |
| PMCID: | PMC10506398 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 October 2022 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
Related MSK Work