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

NCT00309491 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2021

Last updated 2020-10-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Austrian Breast & Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Raimund Jakesz, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1990-12-31
Primary Completion
1996-01-31
Completion
2000-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00309491 on ClinicalTrials.gov