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

Completed

• Conditions: Atypical Ductal Hyperplasia (ADH) of the Breast

• Registration Number: NCT01925586
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-19
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications)	5 years	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.

Secondary Outcome Measures

Name	Time	Method
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.	5 years	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.

Trial Locations

Locations (1)

Yale University & Smilow Breast Center at Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States