Surgical Tissue Evaluation for Breast Abnormalities

No longer recruiting at 24 trial locations

Overseen By Faina Nakhlis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Invasive breast cancer, DCIS, ADH, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a surgical approach to determine the presence of cancer in women diagnosed with certain breast conditions, such as flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA). The goal is to examine surgically removed tissue to confirm the initial diagnosis. Women who have undergone breast imaging leading to a core needle biopsy, revealing these specific conditions, and who do not have invasive breast cancer, may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance diagnostic accuracy for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this surgical intervention is safe for evaluating breast abnormalities?

Studies have shown that removing and examining tissue is a safe procedure for checking breast tissue for cancer. Research indicates that when flat epithelial atypia (FEA) is found, usually no further action is needed, suggesting it is not typically harmful. For intraductal papilloma, a small, non-cancerous tumor in a breast duct, the procedure helps ensure there isn't a more serious issue. These findings suggest the procedure is well-tolerated and has a good safety record for assessing these types of breast abnormalities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pathologic evaluation of excised tissue for breast abnormalities because it offers a more precise way to diagnose conditions like intraductal papilloma without atypia (IPWA) and flat epithelial atypia (FEA). Unlike traditional imaging techniques, this method involves examining the actual tissue, which can provide a clearer and more detailed understanding of the abnormality. This approach helps ensure that patients receive the most accurate diagnosis, potentially leading to more personalized and effective treatment plans. By focusing on direct tissue analysis, this technique could improve diagnostic accuracy and patient outcomes.

What evidence suggests that this pathologic evaluation is effective for ruling out cancer in breast abnormalities?

Research has shown that when flat epithelial atypia (FEA) appears in a breast biopsy, there is a small chance—about 4.5%—that it could indicate something more serious, such as cancer. For intraductal papilloma without atypia, doctors often recommend additional surgery, particularly if high-risk factors are present. In this trial, participants will undergo a pathologic evaluation of excised tissue to thoroughly check for any concerning breast conditions. Examining the removed tissue allows doctors to determine if these conditions are more serious. This approach aims to identify hidden issues early, leading to better patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Faina Nakhlis, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women diagnosed with flat epithelial atypia or intraductal papilloma without atypia by core needle biopsy. Participants must be over 18, not pregnant or breastfeeding, and have had a BIRADS level 1-4 lesion. They should sign informed consent and join within 100 days post-biopsy.

Inclusion Criteria

The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion

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

I am a woman.

Exclusion Criteria

I have or had invasive breast cancer or DCIS.

My biopsy showed atypical ductal hyperplasia.

A BIRADS 5 lesion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Participants undergo excisional biopsy to rule out the presence of cancer near the initial core biopsy site

1 day

1 visit (in-person)

Pathologic Evaluation

Pathologic evaluation of excised tissue to identify the presence of cancer

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the surgical intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pathologic evaluation of excised tissue

Trial Overview The study tests surgical removal of breast tissue to check for cancer in patients previously identified with certain non-cancerous conditions through biopsy. The excised tissue undergoes detailed pathologic evaluation.

How Is the Trial Designed?

Group I: Pathologic evaluation of excised tissue Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10516722/

Isolated Flat Epithelial Atypia: Upgrade Outcomes After ... Isolated flat epithelial atypia (FEA) diagnosed by image-guided breast biopsy had an overall 4.5% upgrade rate. Multidisciplinary review using ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10110831/

Management of Intraductal Papilloma of the Breast Diagnosed ... This article concludes that further surgery is recommended for IDPs without atypia diagnosed on CNB who have high-risk factors.

3. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(11)60413-8/fulltext

Clinician's Guide to Imaging and Pathologic Findings in ... Flat epithelial atypia has been recognized as a risk marker for worrisome lesions, such as atypical ductal hyperplasia, atypical lobular hyperplasia, and even ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0893395222032434

Clinical and pathologic features of ductal carcinoma in situ ... Additionally, flat epithelial atypia was significantly associated with the presence of atypical ductal hyperplasia, lobular neoplasia, and columnar cell lesions ...

5. tandfonline.com tandfonline.com/doi/full/10.2217/bmt-2020-0028

Full article: Papillary Lesions of the Breast: A Review Papillary lesions can be both benign and malignant and they comprise a variety of lesions including intraductal papilloma (IDP), IDP with atypia or ductal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7571817/

A retrospective observational study of intraductal breast ... The aim of the study is to investigate the intraductal breast papilloma and its coexisting lesions retrospectively in real‐world practice.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5079293/

Pathologic High Risk Lesions, Diagnosis and Management Papillary breast lesions are a heterogenous group of lesions that include benign intraductal papilloma, papilloma with atypia and papillary carcinomas.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000296102400134X

Outcomes of benign intraductal papillomas diagnosed on ... About 3–6% of breast core biopsies (CB) result in a diagnosis of intraductal papilloma, which may be benign or associated with atypia or malignancy.1,2 The ...

9. cancer.org cancer.org/cancer/diagnosis-staging/tests/biopsy-and-cytology-tests/understanding-your-pathology-report/breast-pathology/benign-breast-conditions-pathology.html

Your Breast Pathology Report: Benign Breast Conditions If flat epithelial atypia is found on an excisional biopsy, most often no further action is needed. If flat epithelial atypia is seen on a ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1875918125000261?dgcid=rss_sd_all

High-Risk Breast Lesions on Core Biopsy This review will summarize some of the available data and discuss who, if any, may safely forego excision following a core biopsy diagnosis of high-risk breast ...