Do benign breast findings hide hidden cancer? study investigates.
NCT ID NCT02489617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 246 women who had a breast biopsy showing either flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA), which are non-cancerous changes. The goal was to see how often these women had cancer (invasive carcinoma or DCIS) in the same breast area. Researchers reviewed the tissue from surgery to find the rate of hidden cancer, helping doctors decide if more surgery is needed after such a biopsy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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246 people
The number who actually took part.
- Started
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Sep 2015
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women all races and ethnic groups are eligible for this trial. This trial is open to the accrual of women only. * Patients must be women * Patients must be at least 18 years of age * Patients must have an imaging abnormality that necessitated a core needle biopsy * The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion * There is documented concordance\* between the initial breast imaging finding and the core biopsy pathology report. The core needle biopsy must contain FEA or IPWA, according to the local pathologist. (It is possible that the central pathology review which is done after the patient is registered on this protocol will have a diagnosis discrepant from that made by the original institution's pathologist. In that case, the study team will communicate this to the original institution's site investigator within one week of the date of the central pathology review having been finalized). Patients may have a personal history of prior or concurrent fibroadenoma and a prior history of proliferative breast lesions with or without atypia. * Patients must be registered on study within 100 days after core needle biopsy. * Patients must have an ability to understand and the willingness to sign a written informed consent document. The patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research. * Concordance is a determination by the radiologist (or his or her covering provider) performing an image-guided core needle biopsy that the pathology report from this procedure corresponds to the imaging appearance of a given lesion and that the said lesion's most representative portion has been sampled. Exclusion Criteria: * Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS * Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA * Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge) * A BIRADS 5 lesion * Discordance between the initial breast imaging finding and the core biopsy pathology report * The presence of atypical ductal hyperplasia (ADH) on core biopsy * Known current pregnancy. A pregnancy test is not required for this exclusion criteria. * Women who are breastfeeding * Patient registered on study more than 100 days since the date of core needle biopsy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Duke University
Durham, North Carolina, 27710, United States
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Georgetown University
Washington D.C., District of Columbia, 20007, United States
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Howard County General Hospital
Columbia, Maryland, 21044, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
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MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Memorial SLoan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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University of North Carolina - Hillsborough Campus
Hillsborough, North Carolina, 27278, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States