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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University & Smilow Breast Center at Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Brigid Killelea, MD, Yale University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Hyperplasia; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 1304011944