The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy

Completed · Not applicable

Conditions studied: Flat Epithelia Atypia, Intraductal Papilloma Without Atypia

In brief

This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy.

Key facts

Study ID

NCT02489617

Run by

Dana-Farber Cancer Institute

People needed

246

Starts

2015-09-01

Expected to finish

2025-06-01

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Indiana University — Indianapolis, Indiana, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• MedStar Franklin Square Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Howard County General Hospital — Columbia, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial SLoan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of North Carolina - Hillsborough Campus — Hillsborough, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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