Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer

NCT00004205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8028

Last updated 2017-12-12

No results posted yet for this study

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.

PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.

Conditions

Interventions

DRUG

letrozole

Letrozole 2.5 mg daily oral administration.

DRUG

tamoxifen citrate

Tamoxifen 20 mg daily oral administration.

Sponsors & Collaborators

  • UNICANCER

    collaborator OTHER
  • Danish Breast Cancer Cooperative Group

    collaborator OTHER
  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Beat Thurlimann, MD · Cantonal Hospital of St. Gallen

  • Louis Mauriac, MD · Institut Bergonié

  • Henning T. Mouridsen, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2008-12-31
Completion
2016-06-30

Countries

  • Denmark
  • France
  • Switzerland

Study Locations

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Entities

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 NCT00004205 on ClinicalTrials.gov