Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)

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.

Inclusion criteria

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.

Exclusion criteria

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.