A double blind randomised clinical trial of adjuvant aminoglutethimide versus placebo given to post menopausal patients with histologically confirmed stage II breast cancer.
A multicentre double blind trial is underway to evaluate aminoglutethimide (AG) (Orimeten, Ciba) 1.000 mg/day with hydrocortisone (HC) 20-40 mg/day versus placebo for adjuvant treatment of post menopausal patients with histologically confirmed stage II breast cancer. An interim analysis in February 1985 indicates that of 338 patients randomised 165 received AG + HC and 173 received placebo. At this time 143 AG + HC patients and 141 placebo patients were eligible and assessible for analysis. Of those who received AG + HC 41 have developed metastases and 27 died compared to placebo patients, 53 of whom have developed metastases (p = 0.04) and 34 have died (p = 0.21). These results are similar to the reported advantages for adjuvant tamoxifen given for stage II breast cancer.
D000368:Aged; D000616:Aminoglutethimide / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008593:Menopause; D010919:Placebos; D011897:Random Allocation; D011960:Receptors, Estrogen / Q000032:analysis
D010919:Placebos; D011960:Receptors, Estrogen; D000616:Aminoglutethimide