test

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

Conditions

Trial Phase

Phase Pilot

Trial Purpose and Description

Trial Purpose

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.


Participation Guidelines

Age:
40 Years and older
Gender:
Female

Eligibility Criteria

Inclusion Criteria

A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:

  1. Pre- and post-menopausal women &ge 40 years of age with newly diagnosed ADH, histologically confirmed on breast core biopsy.
  2. Ability to understand and the willingness to sign a written informed consent document.
  3. Willing to schedule definitive resection of ADH if randomized to surgical excision arm or be observed if randomized to the observation arm.
  4. 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:

  1. Patients with a current breast cancer diagnosis or a personal history of cancer
  2. Patients with a personal history of an identifiable genetic mutation (BRCA) for breast cancer and, untested first degree relatives of mutation carriers
  3. Patients who have previously or are currently taking tamoxifen or exemestane or other chemotherapy or biologic therapy (e.g. trastuzumab)
  4. Patients with a history of radiation therapy to the chest wall
  5. Pregnant and/or lactating women within past 6 months.
Sponsor:
Yale Cancer Center
Dates:
08/20/2013
Last Updated:
Study HIC#:
1304011944