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Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2672

Last updated 2026-02-06

Study results available
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Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Conditions

Interventions

DRUG

exemestane

DRUG

tamoxifen

DRUG

triptorelin

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Breast International Group

    collaborator OTHER

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Olivia Pagani, MD · Oncology Institute of Southern Switzerland

  • Barbara Walley, MD, FRCPC · Tom Baker Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-03
Primary Completion
2011-03-11
Completion
2024-10-23

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Egypt
  • Germany
  • Hungary
  • India
  • Italy
  • New Zealand
  • Peru
  • Slovenia
  • South Africa
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00066703 on ClinicalTrials.gov