Atypical Ductal Hyperplasia (ADH) of the BreastALCOVENCT01925586
Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)
An observational study of Atypical Ductal Hyperplasia (ADH) of the Breast, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Atypical Ductal Hyperplasia (ADH) of the Breast
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2018
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the Breast Clinic at Smilow for evaluation and management of ADH will be identified. After screening and informed consent, patient demographics and study specific data points will be obtained by interview and chart review. Patients will then be randomized to surgical excision or close observation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University & Smilow Breast Center at Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Atypical Lesions of the Breast: Close Observation vs. Excision
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.
Read the detailed description
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.
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What is being measured
The primary outcome is the main question the study is designed to answer.
Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications)
Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications) in the observation period will be subject to biopsy; pathology results indicating in situ or invasive disease will prompt multi-disciplinary treatment consistent with established standards of care.Patients in the close observation group will be assessed at six months and annually thereafter with clinical examination and breast imaging. Patients in the surgery group will be followed with yearly clinical breast exam and yearly breast imaging.
Measured: 5 years
Secondary outcomes (1)
Quality of life, patient satisfaction and costs between the two groups will be measured by the Functional Assessment of Chronic Illness Therapy (FACIT), specifically the FACT-G and the FACT-Es.
The FACT-GP will measure physical well-being, social/family well-being, emotional well-being and functional well-being. Higher scores indicate better well-being.
The FACT-Es will be used to assess symptoms related to menopause and tamoxifen or exemestane, as we anticipate many of the subjects will be on endocrine therapy as part of their chemo-prevention.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Ductal Hyperplasia (ADH) of the BreastStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigid Killelea, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925586
- Sponsor's protocol ID
- 1304011944
- Acronym
- ALCOVE
- Status last verified
- Jan 2019
- First submitted
- 12 Aug 2013
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No