The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
452
Objective tumour response
Time frame: Assessed at 3 months
Pathological response
Time frame: Assessed at 3 months
Extent of breast surgery
Time frame: Assessed at 3 months
Extent of axillary down-staging
Time frame: Assessed at 3 months
Clinical ultrasound response versus clinical caliper response
Time frame: Assessed at 3 months
Safety
Time frame: Assessed up to 5 years + 30 days
Complications due to surgery
Time frame: Assessed up to 30 days post-surgery
Health economics outcomes
Time frame: Assessed up to 30 days post-surgery
Quality of Life assessments
Time frame: Assessed at 3 months
Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
Time frame: Assessed up to 5 years + 30 days
Recurrence-free survival and survival
Time frame: Assessed up to 5 years
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Research Site
Santa Rosa, California, United States
Research Site
New Britain, Connecticut, United States
Research Site
Torrington, Connecticut, United States
Research Site
Springfield, Illinois, United States
Research Site
Mason City, Iowa, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Pittsfield, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Portland, Oregon, United States
...and 69 more locations