Clinical trial NCT01925586: Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)
Official title: Atypical Lesions of the Breast: Close Observation vs. Excision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atypical Ductal Hyperplasia (ADH) of the Breast
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 9
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

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 ≥ 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.

Primary outcomes:
measure: Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications)
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University & Smilow Breast Center at Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Brigid Killelea, MD
role: PRINCIPAL_INVESTIGATOR
References: