# Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic breast cancer

Source: https://onco.cc/key-papers/paper-gucalp-bicalutamide-ar-positive-tbcrc011-ccr-2013/  
OnCo record `paper-gucalp-bicalutamide-ar-positive-tbcrc011-ccr-2013` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Screening 424 women with ER-negative breast cancer found androgen receptor in 12%; the prostate drug bicalutamide held the disease stable for six months in 19% of them, the first clinical proof that the LAR subtype can be treated through its receptor.

## Summary

TBCRC 011 tested bicalutamide 150 mg daily in ER/PgR-negative advanced breast cancer with central AR immunohistochemistry (over 10% nuclear staining positive). Of 424 patients screened, 12% were AR-positive. The six-month clinical benefit rate was 19% (95% CI 7 to 39) and median progression-free survival 12 weeks; no grade 4 or 5 treatment-related events occurred.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Clinical Cancer Research
- Year: 2013
- DOI: 10.1158/1078-0432.CCR-12-3327
- Authors: Gucalp A, Tolaney S, Isakoff SJ, et al.
- Findings: AR-positive (over 10% nuclear staining) in 12% of 424 ER/PgR-negative patients.; Six-month clinical benefit rate 19%; median PFS 12 weeks.
- What it means: It fixes the AR-positive share of ER-negative disease at about one in eight and shows anti-androgens give modest, non-toxic benefit, the rationale for enzalutamide and later CDK4/6 and PI3K combinations in LAR tumours.
- Caveats: 26 treated patients; single-arm.; AR positivity threshold of 10% differs from the enzalutamide trial's any-staining rule.

## Sources

- Gucalp et al., Clin Cancer Res 2013: bicalutamide in AR-positive, ER-negative metastatic breast cancer (TBCRC 011): https://doi.org/10.1158/1078-0432.CCR-12-3327
- PubMed: https://pubmed.ncbi.nlm.nih.gov/23965901/

## 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: [Bicalutamide](https://onco.cc/drugs/bicalutamide/)
- institutions: [Memorial Sloan Kettering Cancer Center](https://onco.cc/institutions/mskcc/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/)
- terms: [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)
- people: [Hope S. Rugo](https://onco.cc/people/hope-rugo/), [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/)
- journals: [Clinical Cancer Research](https://onco.cc/journals/clinical-cancer-research/)

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