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

This study has been terminated.
(Poor recruitement)
The Danish Medical Research Council
Danish Cancer Society
Information provided by (Responsible Party):
Bent Ejlertsen, Danish Breast Cancer Cooperative Group Identifier:
First received: May 26, 2009
Last updated: February 13, 2015
Last verified: February 2015
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:

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 ]

Enrollment: 123
Study Start Date: May 2009
Estimated Study Completion Date: June 2024
Primary Completion Date: December 2013 (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00908531

Dept. of Breast Surgery; Aalborg Sygehus
Aalborg, Denmark, DK-9000
Dept. of Breast Surgery; Rigshospitalet
Copenhagen, Denmark, DK-2100
Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
Esbjerg, Denmark, DK-6700
Dept. of Breast Surgery; Herlev Hospital
Herlev, Denmark, DK-2730
Dept. of Oncology; Odense University Hospital
Odense, Denmark, DK-5000
Depart. of Breast Surgery, Ringsted Sygehus
Ringsted, Denmark, 4100
Dept. of Breast Surgery; Vejle Sygehus
Vejle, Denmark, DK-7100
Dept. of Breast Surgery; Regionshospitalet Viborg
Viborg, Denmark, DK-8800
Dept. of Surgery; Århus Sygehus
Århus, Denmark, DK-8000
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
The Danish Medical Research Council
Danish Cancer Society
Principal Investigator: Bent Ejlertsen, MD, PhD DBCG
  More Information

No publications provided

Responsible Party: Bent Ejlertsen, Professor, MD, PhD, Danish Breast Cancer Cooperative Group Identifier: NCT00908531     History of Changes
Other Study ID Numbers: DBCG 07-REAL
Study First Received: May 26, 2009
Last Updated: February 13, 2015
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
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 30, 2015