, all patients diagnosed with primary invasive breast cancer
on breast core needle biopsy performed at The Ohio State University Wexner
Medical Center (OSUWMC) during December 1, 2013 to November 30, 2017, will be
identified from the anatomic pathology electronic database. Outside cases
reviewed at OSUWMC and cases in which biomarkers were performed at outside
laboratories will be excluded. The following data will be collected: date of
procedure, type of procedure (biopsy or excision), patient age, histologic
type, tumor grade (1, 2 or 3),
estrogen receptor (ER) and progesterone receptor (PR) status (positive or
negative, percentage of tumor cells staining positive), HER2 IHC score (0, 1+,
2+, 3+) and HER2 FISH result (positive, negative, equivocal, indeterminate, HER2/CEP17
ratio, and average HER2 signals per cell). At OSUWMC, HER2 status is routinely
determined by the simultaneous use of both IHC and FISH on all core biopsies
with sufficient invasive carcinoma for co-testing. All cases will be scored
according to 2013 ASCO/CAP HER2 Guidelines and the 2018 revised guidelines.

Cases of bilateral disease were recorded separately. In cases of multifocal
ipsilateral disease in which HER2 status differed between foci or if there was
intratumoral heterogeneity for HER2 expression, the highest (most positive)
HER2 result will be recorded. 

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