Clinical trial NCT02489617: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flat Epithelia Atypia
Intraductal Papilloma Without Atypia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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
* 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.

Primary outcomes:
measure: Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review
timeFrame: 60 days
Secondary outcomes:
measure: Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review
timeFrame: 60 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: District of Columbia
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington, D.C.
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Franklin Square Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial SLoan Kettering Bergen
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Hillsborough
country: United States
facility: University of North Carolina - Hillsborough Campus
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Faina Nakhlis, MD
role: PRINCIPAL_INVESTIGATOR
References: