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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:September 2015
End Date:June 2022
Contact:Faina Nakhlis, MD
Email:fnakhlis@partners.org
Phone:617-983-7777

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
20
sites
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Shelley Hwang, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Lisa Jacobs, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Catherine Parker, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Rouzan G Karabakhtsian, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Kandice Ludwig, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Priscilla McAuliffe, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Sara Javid, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Catherine Van Poznak, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Baltimore, Maryland 21218
Principal Investigator: Shawna Willey, MD
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21237
Principal Investigator: Shawna Willey, MD
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Faina Nakhlis, MD
Phone: 617-983-7777
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Kristalyn K. Gallagher, DO
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Columbia, Maryland 21045
Principal Investigator: Lisa Jacobs, MD
?
mi
from
Columbia, MD
Click here to add this to my saved trials
430 Waterstone Drive
Hillsborough, North Carolina 27278
Principal Investigator: Kristalyn K. Gallagher, DO
?
mi
from
Hillsborough, NC
Click here to add this to my saved trials
Middletown, New Jersey 07748
Principal Investigator: Melissa Pilewskie, MD
?
mi
from
Middletown, NJ
Click here to add this to my saved trials
225 Summit Avenue
Montvale, New Jersey 07645
?
mi
from
Montvale, NJ
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Melissa Pilewskie, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
Washington, District of Columbia
Principal Investigator: Shawna Willey, MD
?
mi
from
Washington,
Click here to add this to my saved trials
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Shawna C Willey, MD
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
?
mi
from
Washington,
Click here to add this to my saved trials
5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Principal Investigator: Lisa Jacobs, MD
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
?
mi
from
Washington,
Click here to add this to my saved trials