Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2012-11-30

Brief Summary

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The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.

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Detailed Description

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Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.

* The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
* In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.

Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women 20 years of age or older
* Imaging abnormality necessitating a core needle biopsy
* Core needle biopsy revealing ALH or LCIS
* Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia

Exclusion Criteria

* History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
* A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
* Received tamoxifen in the past

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No