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

Source: https://onco.cc/key-papers/paper-traina-enzalutamide-ar-tnbc-jco-2018/  
OnCo record `paper-traina-enzalutamide-ar-tnbc-jco-2018` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Enzalutamide gave clinical benefit at 16 weeks to a quarter of women with androgen receptor-expressing triple-negative breast cancer, a third among those with 10% or more staining, with fatigue the only common severe side effect.

## Summary

Phase 2 study of enzalutamide 160 mg daily in locally advanced or metastatic AR-positive TNBC (nuclear AR staining above 0% by a breast-optimised assay). Of 118 enrolled, 78 were evaluable (10% or more nuclear AR with a post-baseline assessment). Clinical benefit at 16 weeks was 25% (intention-to-treat) and 33% (evaluable); median progression-free survival 2.9 and 3.3 months; median overall survival 12.7 and 17.6 months. Fatigue was the only grade 3 or higher related event above 2%.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Journal of Clinical Oncology
- Year: 2018
- DOI: 10.1200/JCO.2016.71.3495
- Authors: Traina TA, Miller K, Yardley DA, et al.
- Findings: Clinical benefit at 16 weeks 25% (ITT) and 33% (AR 10% or more).; Median overall survival 12.7 (ITT) and 17.6 months (evaluable).
- What it means: Enzalutamide works modestly in AR-positive TNBC and is the reference for the LAR subtype's therapy implication; the AR threshold used for eligibility changes who counts as positive.
- Caveats: Single-arm phase 2; the phase 3 was not pursued.; A companion gene signature (PREDICT AR) was explored but is not validated.

## Sources

- Traina et al., J Clin Oncol 2018: enzalutamide in AR-expressing TNBC: https://doi.org/10.1200/JCO.2016.71.3495
- PubMed: https://pubmed.ncbi.nlm.nih.gov/29373071/

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [Androgen receptor](https://onco.cc/targets/androgen-receptor/)
- drugs: [Enzalutamide](https://onco.cc/drugs/enzalutamide/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/)
- people: [Eric P. Winer](https://onco.cc/people/eric-winer/), [Peter Schmid](https://onco.cc/people/peter-schmid/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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