Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

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.

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

Interventions

DRUG

Exemestane

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

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Oophorectomy

Undergo bilateral surgical oophorectomy

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo ovarian irradiation

DRUG

Tamoxifen

Tamoxifen 20mg orally daily for 5 years

DRUG

Triptorelin

3.75 mg by im injection q28 days for 5 years

Sponsors & Collaborators

• Breast International Group

  collaborator OTHER

• Cancer and Leukemia Group B

  collaborator NETWORK

• National Cancer Institute (NCI)

  collaborator NIH

• NSABP Foundation Inc

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• North Central Cancer Treatment Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• ETOP IBCSG Partners Foundation

  lead NETWORK

Principal Investigators

• Gini Fleming · ETOP IBCSG Partners Foundation

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

2003-12-17

Primary Completion

2014-05-31

Completion

2024-11-06

Countries

• United States
• Canada
• Switzerland

Study Locations