Phase II Trial of Bicalutamide in Patients with Androgen Receptor–Positive, Estrogen Receptor–Negative Metastatic Breast Cancer
By A. Gucalp, S. Tolaney, S. Isakoff, J. Ingle, Minetta C. Liu, Lisa A. Carey, K. Blackwell, H. Rugo, L. Nabell, A. Forero and 12 more. Clinical Cancer Research, 2013
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Purpose: Patients with hormone receptor–negative breast cancer generally do not benefit from endocrine-targeted therapies. However, a subset with androgen receptor (AR) expression is predicted to respond to antiandrogen therapies. This phase II study explored bicalutamide in AR-positive, estrogen receptor (ER), and progesterone receptor (PgR)-negative metastatic breast cancer. Experimental Design: Tumors from patients with ER/PgR-negative advanced breast cancer were tested centrally for AR [immunohistochemistry (IHC) > 10% nuclear staining considered positive]. If either the primary or a metastatic site was positive, patients were eligible to receive the AR antagonist bicalutamide at a dose of 150 mg daily. Clinical benefit rate (CBR), the primary endpoint, was defined as the total number of patients who show a complete response (CR), partial response (PR), or stable disease (SD) > 6 months; secondary endpoints included progression-free survival (PFS) and toxicity. Correlative studies included measurement of circulating endocrine markers and IHC surrogates for basal-like breast cancer. Results: Of 424 patients with ER/PgR-negative breast cancer, 12% tested AR-positive. The 6-month CBR was 19% [95% confidence interval (CI), 7%–39%] for bicalutamide. The median PFS was 12 weeks (95% CI, 11–22 weeks). Bicalutamide was well-tolerated with no grade 4/5 treatment-related adverse events observed. Conclusion: AR was expressed in 12% of patients with ER/PgR-negative breast cancer screened for this trial. The CBR of 19% observed with bicalutamide shows proof of principle for the efficacy of minimally toxic androgen blockade in a select group of patients with ER/PgR-negative, AR-positive breast cancer. Clin Cancer Res; 19(19); 5505–12. ©2013 AACR.
Subfields: Cancer Research, Genetics, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/cd2ca5b7abbb4e92cc4117d4b0635a5d964b565e
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In Pulmonary and Respiratory Medicine
Citations in the corpus
- Risk Factors and Preventions of Breast Cancer (2017, background): “Expressions of AR is observed in 30% of TNBC patients, and the AR inhibitor bicalutaminde showed a clinical benefit rate of 19% in ER/PR negative breast cancer patients in a phase II study [138,139].”
- Recent advances in therapeutic strategies for triple-negative breast cancer (2022, background): “Finally, 26 cases completed the study regimen with a clinical benefit rate of 19% at 6 months and a median PFS of 12 weeks [40].”
- Triple-negative breast cancer molecular subtyping and treatment progress (2020, methodology): “performed antiandrogen therapy on LAR-subtype TNBC patients and found that this group of patients could benefit from antiandrogen treatment [56].”