Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
NCT ID: NCT00908531
Last Updated: 2019-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
123 participants
INTERVENTIONAL
2009-05-31
2013-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Postoperative letrozole
Definitive surgery without preoperative AI treatment
letrozole (Femara)
tablet 2.5 mg daily
Preoperative letrozole
Treatment with letrozole for 4 months before definitive surgery.
letrozole (Femara)
tablet 2.5 mg daily
Interventions
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letrozole (Femara)
tablet 2.5 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
FEMALE
No
Sponsors
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The Danish Medical Research Council
OTHER
Danish Cancer Society
OTHER
Novartis
INDUSTRY
Danish Breast Cancer Cooperative Group
OTHER
Responsible Party
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Bent Ejlertsen
Professor, MD, PhD
Principal Investigators
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Bent Ejlertsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
DBCG
Locations
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Dept. of Breast Surgery; Aalborg Sygehus
Aalborg, , Denmark
Dept. of Surgery; Århus Sygehus
Aarhus, , Denmark
Dept. of Breast Surgery; Rigshospitalet
Copenhagen, , Denmark
Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
Esbjerg, , Denmark
Dept. of Breast Surgery; Herlev Hospital
Herlev, , Denmark
Dept. of Oncology; Odense University Hospital
Odense, , Denmark
Depart. of Breast Surgery, Ringsted Sygehus
Ringsted, , Denmark
Dept. of Breast Surgery; Vejle Sygehus
Vejle, , Denmark
Dept. of Breast Surgery; Regionshospitalet Viborg
Viborg, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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DBCG 07-REAL
Identifier Type: -
Identifier Source: org_study_id
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