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TBCRC 034: Ductal Carcinoma in Situ (DCIS) - Clinical Trial

What is the Purpose of this Study?

Flat epithelia atypia (FEA) and intraductal papilloma without atypia (IPWA) are changes seen within the milk ducts. We are able to catch this diagnosis easier due to core needle biopsies, which is an accurate method that does not involve surgery.

We are doing this study to see how often cancer is found by surgical biopsy, after the original core needle biopsy was done that diagnosed the FEA or IPWA. We hope these findings will help doctors to better advise you on whether to get a surgical biopsy to get rid of your cancer.

What is the Condition Being Studied?

Breast Cancer (flat epithelial atypia (FEA), intraductal papilloma without atypia (IPWA))

Who Can Participate in the Study?

Adult women who have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy and no prior history of invasive breast cancer or ductal carcinoma in situ (DCIS).

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:

- Confirm that a core needle biopsy was done and it showed FEA or IPWA.
- Have tests, exams, scans, and answer questionnaires.
- Be randomized (put into one of two groups by chance like a flip of a coin) to get either
--- Group 1: surgery up to 6 months from diagnosis - this is a procedure where the area of the breast tissue to have the FEA or IPWA is removed by the surgeon.
--- Group 2: physical exams and breast tissue analysis - up to 3 months after surgery.
- Be in the study for up to 9 months

Study Details

Full 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
Principal Investigator
Surgical Oncologist
Protocol Number
IRB:PRO00066589
NCT:NCT02489617
Phase
Phase N/A
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698