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Surgical Tissue Evaluation for Breast Abnormalities

N/A
Waitlist Available
Led By Faina Nakhlis, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be women
Patients must be at least 18 years of age
Must not have
Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS
Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a surgery to see if cancer is present in patients that have had abnormal growths found in a breast biopsy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this trial involves surgical intervention, potential side effects may include pain, infection risk at the incision site, bleeding, scarring, and possible complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman.
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I am 18 years old or older.
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I had a biopsy because of an unusual image on my scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had invasive breast cancer or DCIS.
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My biopsy showed I have FEA or IPWA.
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My biopsy showed atypical ductal hyperplasia.
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I have abnormal nipple discharge from one duct.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pathologic evaluation of excised tissueExperimental Treatment1 Intervention
Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
352,851 Total Patients Enrolled
Faina Nakhlis, MD4.712 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
1 Previous Clinical Trials
78 Total Patients Enrolled
5Patient Review
Dr. Nakhlis is a top-tier professional. Not only is she an excellent surgeon, she is kind and compassionate. I feel fortunate to be one of her patients.
~25 spots leftby Sep 2025
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