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 range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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