Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,021
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years) * 1st therapy week:125mg/-/125mg Aminoglutethimide daily * 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily * as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily
Overall survival
Recurrence-free survival
Side-effect profiles
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