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

Primary Purpose

Operable Breast Neoplasms

Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
letrozole (Femara)
Sponsored by
Danish Breast Cancer Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Operable Breast Neoplasms focused on measuring Breast neoplasms, Randomised trial, Aromatase Inhibitors, Preoperative care, Age 60 or older, Hormone receptor positive tumor, Tumor lager than 2 cm, No distant metastasis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Breast Surgery; Aalborg Sygehus
  • Dept. of Breast Surgery; Rigshospitalet
  • Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
  • Dept. of Breast Surgery; Herlev Hospital
  • Dept. of Oncology; Odense University Hospital
  • Depart. of Breast Surgery, Ringsted Sygehus
  • Dept. of Breast Surgery; Vejle Sygehus
  • Dept. of Breast Surgery; Regionshospitalet Viborg
  • Dept. of Surgery; Århus Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Postoperative letrozole

Preoperative letrozole

Arm Description

Definitive surgery without preoperative AI treatment

Treatment with letrozole for 4 months before definitive surgery.

Outcomes

Primary Outcome Measures

pCR
Complete response rate
Clinical tumor response
Ultrasound

Secondary Outcome Measures

Overall survival
Death of any cause

Full Information

First Posted
May 26, 2009
Last Updated
April 25, 2019
Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
The Danish Medical Research Council, Danish Cancer Society, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00908531
Brief Title
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
Acronym
REAL
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitement
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
December 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
The Danish Medical Research Council, Danish Cancer Society, Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operable Breast Neoplasms
Keywords
Breast neoplasms, Randomised trial, Aromatase Inhibitors, Preoperative care, Age 60 or older, Hormone receptor positive tumor, Tumor lager than 2 cm, No distant metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative letrozole
Arm Type
Active Comparator
Arm Description
Definitive surgery without preoperative AI treatment
Arm Title
Preoperative letrozole
Arm Type
Experimental
Arm Description
Treatment with letrozole for 4 months before definitive surgery.
Intervention Type
Drug
Intervention Name(s)
letrozole (Femara)
Other Intervention Name(s)
Femara
Intervention Description
tablet 2.5 mg daily
Primary Outcome Measure Information:
Title
pCR
Description
Complete response rate
Time Frame
At four months
Title
Clinical tumor response
Description
Ultrasound
Time Frame
At four months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Death of any cause
Time Frame
At ten years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bent Ejlertsen, MD, PhD
Organizational Affiliation
DBCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Breast Surgery; Aalborg Sygehus
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Dept. of Breast Surgery; Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
City
Esbjerg
ZIP/Postal Code
DK-6700
Country
Denmark
Facility Name
Dept. of Breast Surgery; Herlev Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Dept. of Oncology; Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Depart. of Breast Surgery, Ringsted Sygehus
City
Ringsted
ZIP/Postal Code
4100
Country
Denmark
Facility Name
Dept. of Breast Surgery; Vejle Sygehus
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
Dept. of Breast Surgery; Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark
Facility Name
Dept. of Surgery; Århus Sygehus
City
Århus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29168427
Citation
Skriver SK, Laenkholm AV, Rasmussen BB, Handler J, Grundtmann B, Tvedskov TF, Christiansen P, Knoop AS, Jensen MB, Ejlertsen B. Neoadjuvant letrozole for postmenopausal estrogen receptor-positive, HER2-negative breast cancer patients, a study from the Danish Breast Cancer Cooperative Group (DBCG). Acta Oncol. 2018 Jan;57(1):31-37. doi: 10.1080/0284186X.2017.1401228. Epub 2017 Nov 23.
Results Reference
background
PubMed Identifier
32410705
Citation
Skriver SK, Jensen MB, Knoop AS, Ejlertsen B, Laenkholm AV. Tumour-infiltrating lymphocytes and response to neoadjuvant letrozole in patients with early oestrogen receptor-positive breast cancer: analysis from a nationwide phase II DBCG trial. Breast Cancer Res. 2020 May 14;22(1):46. doi: 10.1186/s13058-020-01285-8.
Results Reference
derived

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

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