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 range

20 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Breast Neoplasms trials