Clinical Trials /

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

NCT02489617

Description:

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.

Related Conditions:
  • Flat Ductal Epithelial Atypia of the Breast
  • Intraductal Breast Papilloma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief 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
  • 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 IDs

  • ORG STUDY ID: 15-174
  • NCT ID: NCT02489617

Conditions

  • Flat Epithelia Atypia
  • Intraductal Papilloma Without Atypia

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Pathologic evaluation of excised tissueExperimentalPatient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue

    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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review
    Time Frame:60 days
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review
    Time Frame:60 days
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Dana-Farber Cancer Institute

    Last Updated