Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer with tamoxifen-aminoglutethimide-danazol compared to tamoxifen used alone.

Multiple-endocrine therapy with combinations of various types of treatment has not been evaluated properly in spite of the success of individual types of hormone treatment. This paper reports the early results of a randomized controlled clinical trial comparing tamoxifen (10 mg 2 times/day)-amino-glutethimide (250 mg 3 times/day)-danazol (100 mg 3 times/day)-hydrocortisone (20 mg 2 times/day) (TAD) with tamoxifen (10 mg 2 times/day). Analysis of the first 107 assessable patients indicates objective response (criteria of the International Union Against Cancer) in 33% of patients receiving tamoxifen versus 50% of patients receiving TAD. Duration of response to TAD is identical to duration of response to tamoxifen alone. TAD is well tolerated, and toxicity, although greater than or tamoxifen, is acceptable.