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NCT02489617 Clinical Trial

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

Flat Epithelia Atypia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02489617
Other study ID # 15-174
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 2024

Study information
Verified date April 2024
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 246
Est. completion date December 2024
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pathologic evaluation of excised tissue
Up to 3 months after excisional biopsy

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States MedStar Franklin Square Medical Center Baltimore Maryland
United States MedStar Union Memorial Hospital Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Dana Farber Cancer Institute Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States University of North Carolina Chapel Hill North Carolina
United States Howard County General Hospital Columbia Maryland
United States Duke University Durham North Carolina
United States University of North Carolina - Hillsborough Campus Hillsborough North Carolina
United States Indiana University Indianapolis Indiana
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 University of Pittsburgh Pittsburgh Pennsylvania
United States Georgetown University Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review 60 days
Secondary Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review 60 days