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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
tablet 2.5 mg daily
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
pCR
Complete response rate
Time frame: At four months
Clinical tumor response
Ultrasound
Time frame: At four months
Overall survival
Death of any cause
Time frame: At ten years
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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