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Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast Cancer.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Gucalp, Ayca Tolaney, Sara M. Isakoff, Steven Jay Ingle, James N. Liu, Margaret C. Carey, Lisa A. Blackwell, Kimberly Carol Rugo, Hope S. Nabell, Lisle A. Forero, Andres Stearns, Vered Doane, Ashley S. Danso, Michael A. Moynahan, Mary Ellen Momen, Lamia F. González, Joseph M. Akhtar, Arooj Giri, Dilip D. Patil, Sujata Sheshrao Feigin, Kimberly N. Hudis, Clifford A. Traina, Tiffany |
| Copyright Year | 2013 |
| Abstract | 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. |
| Starting Page | 1 |
| Ending Page | 10 |
| Page Count | 10 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://clincancerres.aacrjournals.org/content/clincanres/19/19/5505.full.pdf |
| PubMed reference number | 23965901v1 |
| Alternate Webpage(s) | https://doi.org/10.1158/1078-0432.CCR-12-3327 |
| DOI | 10.1158/1078-0432.ccr-12-3327 |
| Journal | Clinical cancer research : an official journal of the American Association for Cancer Research |
| Volume Number | 19 |
| Issue Number | 19 |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | AR gene Addison Disease Adverse reaction to drug Androgen Antagonists Androgens Basal-Like Breast Carcinoma Carcinoma breast stage IV Confidence Intervals Correlative Study Estrogen Receptors Estrogens Hormone Receptor Immunohistochemistry Mammary Neoplasms Patients Progression-Free Survival Receptors, Progesterone Staining method Subgroup Total Number bicalutamide estrogen receptor alpha, human |
| Content Type | Text |
| Resource Type | Article |
