Clinical trial · Interventional
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitement
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Operable Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole (Femara) | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Postoperative letrozole
- description
- Definitive surgery without preoperative AI treatment
- interventionNames
- Drug: letrozole (Femara)
- type
- EXPERIMENTAL
- label
- Preoperative letrozole
- description
- Treatment with letrozole for 4 months before definitive surgery.
- interventionNames
- Drug: letrozole (Femara)
Primary outcomes (2)
- measure
- pCR
- timeFrame
- At four months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSkriver 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. PMID 29168427
- DERIVEDSkriver 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. PMID 32410705