Incidence of Invasive Breast Cancer and/or Ductal Breast Cancer in Patients with Intraductal Papilloma without Atypia or Flat Epithelial Atypia after Core Needle Biopsy

Inclusion Criteria

• 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 * 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
• Patients must be registered on study within 100 days of the core needle biopsy
• Patients must have an ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• 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
• 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