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Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

NCT00066573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7576

Last updated 2023-08-25

Study results available
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Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer.

PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.

Conditions

Interventions

DRUG

anastrozole

Given orally

DRUG

exemestane

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • ETOP IBCSG Partners Foundation

    collaborator NETWORK

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

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

  • James N. Ingle, MD · Mayo Clinic

  • Matthew J. Ellis, MD, PhD, FRCP · Washington University Siteman Cancer Center

  • George W. Sledge, MD · Indiana University Melvin and Bren Simon Cancer Center

  • George T. Budd, MD · The Cleveland Clinic

  • Manuela Rabaglio, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-06
Primary Completion
2010-11-07
Completion
2012-01-06
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066573 on ClinicalTrials.gov