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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908531
Recruitment Status : Terminated (Poor recruitement)
First Posted : May 27, 2009
Last Update Posted : February 16, 2015
The Danish Medical Research Council
Danish Cancer Society
Information provided by (Responsible Party):
Bent Ejlertsen, Danish Breast Cancer Cooperative Group

Brief 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.

Condition or disease Intervention/treatment Phase
Operable Breast Neoplasms Drug: letrozole (Femara) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2009
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Invasive disease-free survival [ Time Frame: 2020 ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2020 ]
  2. Distant recurrence-free survival [ Time Frame: 2020 ]
  3. Complete pathological response [ Time Frame: 2014 ]
  4. Miller-Payne Score [ Time Frame: 2014 ]
  5. Clinical tumour response [ Time Frame: 2014 ]
  6. Mammographic response [ Time Frame: 2014 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Bent Ejlertsen, Professor, MD, PhD, Danish Breast Cancer Cooperative Group Identifier: NCT00908531     History of Changes
Other Study ID Numbers: DBCG 07-REAL
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Bent Ejlertsen, 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 by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs