OncRef

Clinical Trial: NCT00066703

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:ETOP IBCSG Partners Foundation
Information Provided By:ETOP IBCSG Partners Foundation
Last Update Posted:2026-02-06

Study Overview

Brief 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.

Official Title

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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: exemestane
  • Drug: tamoxifen
  • Drug: triptorelin

Other Study ID Numbers

  • IBCSG 25-02 / BIG 3-02
  • IBCSG 25-02
  • BIG 3-02
  • NABCI IBCSG 25-02
  • EU-20347
  • 2004-000168-28
  • CDR0000316458
  • 2004

Start Date (Actual)

2003-11-03

Primary Completion Date (Actual)

2011-03-11

Study Completion Date (Actual)

2024-10-23

Enrollment (Actual)

2672

Study Type

Interventional

Phase

Phase 3