Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)
Completed
Conditions studied: Atypical Ductal Hyperplasia (ADH) of the Breast
In brief
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.
Key facts
- Study ID
- NCT01925586
- Run by
- Yale University
- People needed
- 9
- Starts
- 2013-08-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2019-01-28
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
- Pre- and post-menopausal women ≥ 40 years of age with newly diagnosed ADH, histologically confirmed on breast core biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to schedule definitive resection of ADH if randomized to surgical excision arm or be observed if randomized to the observation arm.
- Original breast core biopsy specimen available for pathologic review and staining by Yale School of Medicine Department of Pathology.
You may not qualify if…
- A patient/subject will not be eligible for this study if any of the following exclusion criteria are met:
- Patients with a current breast cancer diagnosis or a personal history of cancer
- Patients with a personal history of an identifiable genetic mutation (BRCA) for breast cancer and, untested first degree relatives of mutation carriers
- Patients who have previously or are currently taking tamoxifen or exemestane or other chemotherapy or biologic therapy (e.g. trastuzumab)
- Patients with a history of radiation therapy to the chest wall
- Pregnant and/or lactating women within past 6 months.
Where it is running
- Yale University & Smilow Breast Center at Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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