CompletedNot Applicable

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

United States9 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range40 Years

SexFEMALE

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Inclusion criteria

✓. 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

✕. 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.

What they're measuring

Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications)

Timeframe: 5 years

Trial details

NCT IDNCT01925586

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08

View on ClinicalTrials.gov More Atypical Ductal Hyperplasia (ADH) of the Breast trials