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Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

NCT00908531 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2019-04-29

No results posted yet for this study

Summary

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Conditions

  • Operable Breast Neoplasms

Interventions

DRUG

letrozole (Femara)

tablet 2.5 mg daily

Sponsors & Collaborators

  • The Danish Medical Research Council

    collaborator OTHER

  • Danish Cancer Society

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Danish Breast Cancer Cooperative Group

    lead OTHER

Principal Investigators

  • Bent Ejlertsen, MD, PhD · DBCG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-12-01
Completion
2013-12-01

Countries

  • Denmark

Study Locations

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Entities

Companies

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 NCT00908531 on ClinicalTrials.gov