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

This study is currently recruiting participants.
Verified March 2012 by Danish Breast Cancer Cooperative Group
Sponsor:
Collaborators:
The Danish Medical Research Council
Danish Cancer Society
Novartis
Information provided by (Responsible Party):
Bent Ejlertsen, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:
NCT00908531
First received: May 26, 2009
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Operable Breast Neoplasms
 Drug: letrozole (Femara)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Danish Breast Cancer Cooperative Group:

Primary Outcome Measures:
  • Invasive disease-free survival [ Time Frame: 2020 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2020 ] [ Designated as safety issue: No ]
  • Distant recurrence-free survival [ Time Frame: 2020 ] [ Designated as safety issue: No ]
  • Complete pathological response [ Time Frame: 2014 ] [ Designated as safety issue: No ]
  • Miller-Payne Score [ Time Frame: 2014 ] [ Designated as safety issue: No ]
  • Clinical tumour response [ Time Frame: 2014 ] [ Designated as safety issue: No ]
  • Mammographic response [ Time Frame: 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: May 2009
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Postoperative letrozole
Definitive surgery without preoperative AI treatment followed post-operatively by 5 AI for years.
 Drug: letrozole (Femara)
tablet 2.5 mg daily
Other Name: Femara
Experimental: Preoperative letrozole
Treatment with letrozole for 4 months before definitive surgery. Post-operatively patients with responsive or stationary tumors continue letrozole to a total of 5 years. Patients with endocrine resistant tumors are re-considered for chemotherapy.
 Drug: letrozole (Femara)
tablet 2.5 mg daily
Other Name: Femara

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908531

Contacts
Contact: Bent Ejlertsen, MD, PhD 0045 3545 8497 ejlertsen@rh.dk
Contact: Ann Raaberg, Nurse 0045 3525 3421 ar@dbcg.dk

Locations
Denmark
Dept. of Breast Surgery; Aalborg Sygehus Recruiting
Aalborg, Denmark, DK-9000
Contact: Jens Peter Garne, MD         jpg@rn.dk    
Dept. of Breast Surgery; Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Niels Kroman, MD     45-3545-5088     niels.kroman@rh.regionh.dk    
Dept. of Surgery; Sydvestjysk Sygehus Esbjerg Recruiting
Esbjerg, Denmark, DK-6700
Contact: Nils R. Rasmussen, MD         Nils.Ryegaard.Rasmussen@svs.regionsyddanmark.dk    
Dept. of Breast Surgery; Herlev Hospital Recruiting
Herlev, Denmark, DK-2730
Contact: Hanne Galatius, MD         hgalatius@heh.regionh.dk    
Dept. of Oncology; Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Marianne E. Kvistgaard, MD         marianne.ewertz@ouh.regionsyddanmark.dk    
Depart. of Breast Surgery, Ringsted Sygehus Recruiting
Ringsted, Denmark, 4100
Contact: Bo Grundtmann, MD         bdg@regionsjaelland.dk    
Dept. of Breast Surgery; Vejle Sygehus Recruiting
Vejle, Denmark, DK-7100
Contact: Peter A. Wamberg, MD         Peter.Arne.Wamberg@vgs.regionsyddanmark.dk    
Dept. of Breast Surgery; Regionshospitalet Viborg Recruiting
Viborg, Denmark, DK-8800
Contact: Helle Hvid, MD         helle.hvid@sygehusviborg.dk    
Dept. of Surgery; Århus Sygehus Recruiting
Århus, Denmark, DK-8000
Contact: Peer M. Christiansen, MD         peerchri@rm.dk    
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
The Danish Medical Research Council
Danish Cancer Society
Novartis
Investigators
Principal Investigator: Bent Ejlertsen, MD, PhD DBCG
  More Information

No publications provided

Responsible Party: Bent Ejlertsen, Professor, MD, PhD, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00908531     History of Changes
Other Study ID Numbers: DBCG 07-REAL
Study First Received: May 26, 2009
Last Updated: March 5, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Danish Breast Cancer Cooperative Group:
Breast neoplasms
Randomised trial
Aromatase Inhibitors
Preoperative care
 Age 60 or older
Hormone receptor positive tumor
Tumor lager than 2 cm
No distant metastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Letrozole
 Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013