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This study is designed to look at whether it is feasible to observe women with atypical ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.
Full description
We hypothesize that surgical excision may not yield an improvement in survival over hormonal therapy and/or close observation alone in patients who present with ADH on core needle biopsy of the breast. An alternate (non-inferior) strategy for management may be possible, and may be associated with improved quality of life and fewer complications, and lower overall costs. Although several researchers have suggested a clinical trial to investigate this idea this would be the first time it has been done, and could therefore be practice changing.
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Inclusion and exclusion criteria
Inclusion Criteria
A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
Exclusion Criteria
A patient/subject will not be eligible for this study if any of the following exclusion criteria are met:
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Data sourced from clinicaltrials.gov
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