Clinical trial NCT00908531: Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: Danish Cancer Society
name: Novartis
First posted: 2009-05-27
Enrollment: 123
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: pCR
timeFrame: At four months
measure: Clinical tumor response
timeFrame: At four months
Secondary outcomes:
measure: Overall survival
timeFrame: At ten years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of Breast Surgery; Aalborg Sygehus
city: Copenhagen
country: Denmark
facility: Dept. of Breast Surgery; Rigshospitalet
city: Esbjerg
country: Denmark
facility: Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
city: Herlev
country: Denmark
facility: Dept. of Breast Surgery; Herlev Hospital
city: Odense
country: Denmark
facility: Dept. of Oncology; Odense University Hospital
city: Ringsted
country: Denmark
facility: Depart. of Breast Surgery, Ringsted Sygehus
city: Vejle
country: Denmark
facility: Dept. of Breast Surgery; Vejle Sygehus
city: Viborg
country: Denmark
facility: Dept. of Breast Surgery; Regionshospitalet Viborg
city: Århus
country: Denmark
facility: Dept. of Surgery; Århus Sygehus
Study officials:
affiliation: DBCG
name: Bent Ejlertsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.