OncRef

Clinical Trial: NCT00066690

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone 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:2026-08-26

Study Overview

Brief 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.

Official Title

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

Conditions

Estrogen 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

Intervention / Treatment

  • Drug: Exemestane
  • Other: Laboratory Biomarker Analysis
  • Procedure: Oophorectomy
  • Other: Quality-of-Life Assessment
  • Radiation: Radiation Therapy
  • Drug: Tamoxifen
  • Drug: Triptorelin

Other Study ID Numbers

  • IBCSG 24-02 / BIG 2-02
  • NCI-2009-01086
  • CDR0000316456
  • BIG 2-02
  • 2004-000166-13
  • IBCSG-24-02
  • U24CA075362
  • 2004

Start Date (Actual)

2003-12-17

Primary Completion Date (Actual)

2014-05

Study Completion Date (Actual)

2024-11-06

Enrollment (Actual)

3066

Study Type

Interventional

Phase

Phase 3