CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,672 enrolled
Drug / intervention
exemestane +2 moredrug
Likely dose
Exemestane dose not specified; triptorelin (GnRH analogue) dose not specified in provided textAI-extracted
Key inclusion· 6
  • Premenopausal women with histologically confirmed breast cancer
  • Hormone receptor positive (estrogen and/or progesterone receptor positive, at least 10% of tumor cells positive by immunohistochemistry)
  • Completely resected disease with no clinically detectable residual loco-regional axillary disease
  • Tumor confined to breast and axillary nodes, no distant metastases
Key exclusion· 8
  • Prior neoadjuvant or adjuvant chemotherapy
  • Prior neoadjuvant or adjuvant endocrine therapy since breast cancer diagnosis
  • No locally advanced inoperable breast cancer, inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes
  • No distant metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00066703
NCT00066703Phase 3Completed

A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer

ETOP IBCSG Partners Foundation·interventional·Posted Aug 7, 2003·Updated Feb 6, 2026

In Brief

A Phase 3 clinical trial evaluating exemestane, tamoxifen, and 1 other intervention for Breast Cancer. Completed, enrolled 2,672 participants across 228 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Brazil, Canada, Egypt, Germany, Hungary, India, Italy, New Zealand, Peru, Slovenia, South Africa, Sweden, Switzerland, United Kingdom, United States

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartNov 3, 2003
Primary CompletionMar 11, 2011
Study CompletionOct 23, 2024
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 22.9 years ago

Interventions

exemestanedrug

tamoxifendrug

triptorelindrug