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

April 25, 2019 updated by: Bent Ejlertsen, Danish Breast Cancer Cooperative Group

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Dept. of Breast Surgery; Aalborg Sygehus
      • Copenhagen, Denmark, DK-2100
        • Dept. of Breast Surgery; Rigshospitalet
      • Esbjerg, Denmark, DK-6700
        • Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
      • Herlev, Denmark, DK-2730
        • Dept. of Breast Surgery; Herlev Hospital
      • Odense, Denmark, DK-5000
        • Dept. of Oncology; Odense University Hospital
      • Ringsted, Denmark, 4100
        • Depart. of Breast Surgery, Ringsted Sygehus
      • Vejle, Denmark, DK-7100
        • Dept. of Breast Surgery; Vejle Sygehus
      • Viborg, Denmark, DK-8800
        • Dept. of Breast Surgery; Regionshospitalet Viborg
      • Århus, Denmark, DK-8000
        • Dept. of Surgery; Århus Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent
  • Age 60 years or older
  • Measurable non-metastatic and non-inflammatory breast cancer
  • Tumor of 2 cm or larger
  • ER and/or PgR positive tumor
  • Co-morbidity index 0 - 3, e.g., no other serious medical condition

Exclusion Criteria:

  • Prior medical therapy for a malignant disease, including aromatase inhibitors
  • Distant metastasis
  • Need for chemotherapy
  • Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
  • Treatment with a non-approved drug within 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Postoperative letrozole
Definitive surgery without preoperative AI treatment
Drug: letrozole (Femara)
tablet 2.5 mg daily
Other Names:
  • Femara
Experimental: Preoperative letrozole
Treatment with letrozole for 4 months before definitive surgery.
Drug: letrozole (Femara)
tablet 2.5 mg daily
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: At four months
Complete response rate
At four months
Clinical tumor response
Time Frame: At four months
Ultrasound
At four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: At ten years
Death of any cause
At ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Breast Cancer Cooperative Group

Collaborators

Novartis
Danish Cancer Society
The Danish Medical Research Council

Investigators

  • Principal Investigator: Bent Ejlertsen, MD, PhD, DBCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBCG 07-REAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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