NCT00309491

Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients

A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,021 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Early-stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen alone	2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
DRUG	Tamoxifen + Aminoglutethimide	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

Timeline

• Start date: 1990-12-01
• Primary completion: 1996-01-01
• Completion: 2000-03-01
• First posted: 2006-04-03
• Last updated: 2020-10-19