CompletedNot Applicable

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

United States78 participantsStarted 2004-11

Plain-language 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.

Who can participate

Age range20 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Concomittant

Trial details

NCT IDNCT00146536

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-11

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