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Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy

NCT00754845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1918

Last updated 2023-08-25

Study results available
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Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.

Conditions

Interventions

DRUG

letrozole

Given orally

OTHER

placebo

Given orally

Sponsors & Collaborators

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Alliance for Clinical Trials in Oncology

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

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

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
2004-11-23
Primary Completion
2015-12-21
Completion
2017-04-19
FDA Drug
Yes

Countries

  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00754845 on ClinicalTrials.gov