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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Atypical Ductal Hyperplasia (ADH) of the Breast
  • Carcinoma, Intraductal, Noninfiltrating
  • Hyperplasia

NCT number NCT01925586
Study type Observational
Source Yale University
Contact
Status Completed
Phase
Start date August 2013
Completion date August 2018