Flat Epithelia AtypiaNCT02489617
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
A study testing Pathologic evaluation of excised tissue in people with Flat Epithelia Atypia and Intraductal Papilloma Without Atypia, run by Dana-Farber Cancer Institute at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Flat Epithelia Atypia, Intraductal Papilloma Without Atypia
- What is being tested?
- Pathologic evaluation of excised tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2015to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Howard County General Hospital
Columbia, Maryland, 21044
Duke University
Durham, North Carolina, 27710
University of North Carolina - Hillsborough Campus
Hillsborough, North Carolina, 27278
Indiana University
Indianapolis, Indiana, 46202
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial SLoan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Montefiore Medical Center
The Bronx, New York, 10461
Georgetown University
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
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.
Read the 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.
- Being tested
- Pathologic evaluation of excised tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathologic evaluation of excised tissueOther
Up to 3 months after excisional biopsy
| Study group | Role | What they receive |
|---|---|---|
| Pathologic evaluation of excised tissue | Experimental | Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA).
-- Pathologic evaluation of excised tissue Receives: Other: Pathologic evaluation of excised tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review
Measured: 60 days
Secondary outcomes (1)
Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2021
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Epithelia AtypiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faina Nakhlis, MD, Dana-Farber Cancer Institute
- Investigators
- Faina Nakhlis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489617
- Sponsor's protocol ID
- 15-174
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2015
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02489617
- Acronym / sponsor ID
- 15-174
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathologic evaluation of excised tissue | Experimental | Other: Pathologic evaluation of excised tissuePatient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathologic evaluation of excised tissueUp to 3 months after excisional biopsy | Other | Pathologic evaluation of excised tissue |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faina Nakhlis, MD principal investigator
Dana-Farber Cancer Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathologic evaluation of excised tissue in people with Flat Epithelia Atypia and Intraductal Papilloma Without Atypia, run by Dana-Farber Cancer Institute at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.