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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

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ClinicalTrials.gov Identifier: NCT02489617
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Faina Nakhlis, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Flat Epithelia Atypia Intraductal Papilloma Without Atypia Other: Pathologic evaluation of excised tissue Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Pathologic evaluation of excised tissue

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

-- Pathologic evaluation of excised tissue

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489617


Contacts
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Contact: Faina Nakhlis, MD 617-983-7777 fnakhlis@partners.org

Locations
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Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Faina Nakhlis, MD Dana-Farber Cancer Institute
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Responsible Party: Faina Nakhlis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02489617    
Other Study ID Numbers: 15-174
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Papilloma
Papilloma, Intraductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Ductal, Lobular, and Medullary