Operable Breast Neoplasms
Conditions
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
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.
Interventions
tablet 2.5 mg daily
Sponsors
The Danish Medical Research Council
Danish Cancer Society
Novartis
Danish Breast Cancer Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | At four months | Complete response rate |
| Clinical tumor response | At four months | Ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | At ten years | Death of any cause |
Countries
Denmark
Outcome results
None listed