Surgical Tissue Evaluation for Breast Abnormalities

Recruiting at 20 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

246 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+