{"paper_id":"bcf25c00-3bd0-4d92-ac55-e7ddd6dd82dc","body_text":"Summary\nA prospective randomized trial of tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer was conducted from December 1980 to September 1985. Patients were eligible regardless of site of disease, estrogen receptor status, or age. Sixty-two of sixty-three randomized patients were evaluable for response. Overall response for tamoxifen and fluoxymesterone was 11% with 61% stabilization of disease, versus 12% response rate for tamoxifen and danazol with 59% stabilization. Toxicities with tamoxifen and fluoxymesterone were greater with an increase in masculinization. We conclude that the response rates to the combinations of tamoxifen and fluoxymesterone or tamoxifen and danazol reported are equivalent in this study but that the increased toxicity with tamoxifen and fluoxymesterone would make tamoxifen and danazol the treatment of choice if a combination were to be used.\nReferences\nMouridsen HT, Palshof R, Patterson J, Battersby L: Tamoxifen in advanced breast cancer. Cancer Treat Rev 5: 131–141, 1978\nPatterson JS, Battersby LA, Edwards DG: Review of the clinical pharmacology and international experience in advanced breast cancer. Reviews on Endocrine-Related Cancer 9: 563–582, 1981\nWesterberg H: Tamoxifen and fluoxymesterone in advanced cancer: a controlled clinical trial. Cancer Treat Rep 64: 117–121, 1980\nCooperative study. Testosterone propionate therapy in breast cancer. JAMA 188: 1069–1072, 1964\nAllegra JC, Lippman ME, Thompson Bet al.: Distribution, frequency, and quantitative analysis of estrogen, progesterone, androgen, and glucocorticoid receptors in human breast cancer. Cancer Res 39: 1447–1454, 1979\nPotts GO: Pharmacology of danazol. J Int Med Res 5 (Supp 3): 1–14, 1977\nMadanes AE, Farber M: Danazol. Ann Intern Med 96: 625–630, 1982\nCoombes RC, Perez D, Gazet JCet al.: Danazol treatment for advanced breast cancer. Cancer Chemother Pharmacol 10: 194–195, 1983\nTormey DC, Lippman ME, Edwards BK, Cassidy JG: Evaluation of tamoxifen doses with and without fluoxymesterone in advanced breast cancer. Ann Int Med 98: 139–144, 1983\nMcGuire WL, DeLaGarza M: Improved sensitivity in the measurement of estrogen receptor in human breast cancer. J Clin Endocrinol Metab 36: 548–552, 1973\nU.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health: Breast Cancer: Suggested protocol guidelines for combination chemotherapy trials and for combined modality trials. Publication No.(NIH) 78-1192, 1978\nKaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457–481, 1958\nMantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemo Rep 50: 163–170, 1966\nGockerman JP, Spremulli EN, Raney M, Logan T: Randomized comparison of tamoxifen versus diethylstilbestrol in estrogen receptor positive or unknown metastatic breast cancer: a Southwestern Cancer Study Group Trial. Cancer Treat Rep 70: 1199–1203, 1986\nHenderson IC: Endocrine therapy in metastatic breast cancer.In: Harris JR, Hellman S, Henderson IC, Kinne DW (eds) Breast Diseases. J.B. Lippincott, London, 1987, pp. 398–428\nPowles TJ, Gordon C, Coombes RC: Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer with tamoxifen-aminoglutethimide-danazol compared to tamoxifen used alone. Cancer Res (Suppl) 42: 3458–3460, 1982\nIngle JN, Green SJ, Ahmann DLet al: Randomized trial of tamoxifen alone or combined with aminoglutethimide and hydrocortisone in women with metastatic breast cancer. J Clin Oncol 4: 958–964, 1986\nAuthor information\nAuthors and Affiliations\nRights and permissions\nAbout this article\nCite this article\nSwain, S.M., Steinberg, S.M., Bagley, C. et al. Tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer — A randomized study. Breast Cancer Res Tr 12, 51–57 (1988). https://doi.org/10.1007/BF01805740\nIssue date:\nDOI: https://doi.org/10.1007/BF01805740","source_license":"CC0","license_restricted":false}