Letrozole After Tamoxifen in Treating Women With Breast Cancer

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.

Conditions

• Breast Cancer

Interventions

DRUG

letrozole

Given orally

OTHER

placebo

Given orally

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• North Central Cancer Treatment Group

  collaborator NETWORK

• ETOP IBCSG Partners Foundation

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• NCIC Clinical Trials Group

  lead NETWORK

Principal Investigators

• Paul E. Goss, MD, PhD · Massachusetts General Hospital

• James N. Ingle, MD · Mayo Clinic

• Monica Castiglione-Gertsch, MD · Insel Gruppe AG, University Hospital Bern

• Nicholas J. Robert, MD · Fairfax Northern Virginia Hematology Oncology, PC - Fairfax

• Silvana Martino, DO · Saint John's Cancer Institute

• Hyman B. Muss, MD · University of Vermont

• Martine J. Piccart-Gebhart, MD, PhD · Jules Bordet Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

120 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-08-24

Primary Completion

2003-08-22

Completion

2003-10-31

Countries

• Canada
• United Kingdom

Study Locations