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Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

NCT00309478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1099

Last updated 2023-06-29

No results posted yet for this study

Summary

Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.

Conditions

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide 600mg/m2

DRUG

Methotrexate

Methotrexate 40mg/m2

DRUG

Fluorouracil implant

Fluorouracil 600mg/m2

DRUG

Goserelin

Zoladex 3.6mg/28 days for 3 years

DRUG

Tamoxifen

Nolvadex 20mg/day for 5 years

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
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1990-12-31
Primary Completion
2004-06-30
Completion
2004-06-30

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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 NCT00309478 on ClinicalTrials.gov