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

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00146536
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy	Concomittant

Secondary Outcome Measures

Name	Time	Method
Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ

Trial Locations

Locations (2)

Dana-Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States