drugset / Trial / NCT00908531
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
Phase 3
Terminated
123 enrolled
Danish Breast Cancer Cooperative Group
Danish Cancer Society · collabNovartis · collabThe Danish Medical Research Council · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-05
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
Outcome
Outcome not reported
Stopped (Enrollment): “Poor recruitement”
Publications
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |