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

NCT ID: NCT02489617

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

Breast milk is made in lobules and is carried through the ducts toward the nipple. Normal ducts are lined by one layer of cells very similar to each other in appearance. Flat epithelia atypia (FEA) and intraductal papilloma without atypia (IPWA) are changes seen within the milk ducts. In the recent years these lesions have been seen more often, seemingly because more core needle biopsies are being done with the help of a mammogram, ultrasound or breast MRI. The reason for this is there is new technology available which is able to do such biopsies. A core needle biopsy uses a hollow needle to remove samples of tissue from the breast. This is an accurate method that does not involve surgery.

FEA and IPWA are not very common and there are few research studies addressing them. Women found to have FEA or IPWA on core biopsy results may receive conflicting recommendations about how to precede next. It is unclear if more tissue should be removed from the biopsy site to ensure that there is no cancer nearby.

The purpose of this study is to find out how often cancer is identified by excisional biopsy near an initial core biopsy where FEA or IPWA has previously been seen. Depending on these findings doctors will be better able to advise their patients as to whether they need to have a surgical biopsy, when FEA or IPWA are seen on needle biopsy, to rule out the presence of breast cancer.

Conditions

Flat Epithelia Atypia; Intraductal Papilloma Without Atypia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pathologic evaluation of excised tissue

Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA).

-- Pathologic evaluation of excised tissue

Group Type: EXPERIMENTAL

Pathologic evaluation of excised tissue

Intervention Type: OTHER

Up to 3 months after excisional biopsy

Interventions

Pathologic evaluation of excised tissue

Up to 3 months after excisional biopsy

Intervention Type: OTHER

Eligibility Criteria

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
• Women who are breastfeeding
• Patient registered on study more than 100 days since the date of core needle biopsy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Faina Nakhlis, MD

Faina Nakhlis, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faina Nakhlis, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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

Countries

United States

Other Identifiers

15-174

Identifier Type: -

Identifier Source: org_study_id