CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,066 enrolled
Drug / intervention
Exemestane +6 moredrug
Likely dose
Exemestane 25 mg orally daily for 5 years plus ovarian function suppression; or Tamoxifen 20 mg orally daily for 5 years; or Triptorelin 3.75 mg IM every 28 days for 5 yearsAI-extracted
Key inclusion· 6
  • ✓Premenopausal women with estradiol in premenopausal range (confirmed by testing or regular menses for 6 months without hormonal therapy)
  • ✓Resected (surgical) hormone receptor-positive breast cancer (ER and/or PgR ≥10% by immunohistochemistry)
  • ✓Stage I-III disease confined to breast and axillary nodes (internal mammary nodes allowed if sentinel node negative)
  • ✓Proper breast surgery: total mastectomy OR breast-conserving surgery with negative margins and radiation to conserved breast
Key exclusion· 11
  • ✕Postmenopausal status (estradiol not in premenopausal range)
  • ✕Distant metastatic disease
  • ✕Locally advanced or inoperable disease: inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes (unless pathologically negative)
  • ✕Positive final surgical margins (except DCIS at margin if mastectomy performed)

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

Search/NCT00066690
NCT00066690Phase 3Completed
CompareCT.gov

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies 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, Laboratory Biomarker Analysis, and 5 other interventions for Estrogen Receptor Positive Breast Cancer and 7 related conditions. Completed, enrolled 3,066 participants across 500 sites in 3 countries.

Detailed Summary

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
CountriesCanada, Switzerland, United States
CollaboratorsBreast International Group, Cancer and Leukemia Group B, National Cancer Institute (NCI), NSABP Foundation Inc, NCIC Clinical Trials Group, North Central Cancer Treatment Group, SWOG Cancer Research Network

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartDec 17, 2003
Primary CompletionMay 1, 2014
Study CompletionNov 6, 2024
TodayJul 2, 2026
Enrollment to primary: 10.4 yearsPosted 22.9 years ago

Interventions

Exemestanedrug

Exemestane 25mg orally daily for 5 years plus ovarian function suppression

Laboratory Biomarker Analysisother

Correlative studies

Oophorectomyprocedure

Undergo bilateral surgical oophorectomy

Quality-of-Life Assessmentother

Ancillary studies

Radiation Therapyradiation

Undergo ovarian irradiation

Tamoxifendrug

Tamoxifen 20mg orally daily for 5 years

Triptorelindrug

3.75 mg by im injection q28 days for 5 years