Organization

Field Name

ID

Required

KCR

HER2 IHC Summary

34046

yes 

SEER

HER2 IHC Summary

3850

yes 

Note 1 This SSDI is no longer required by any of the standard setters starting with 2021 diagnoses.

  • For cases diagnosed 2021+, this SSDI may be left blank

Note 2 Physician statement of HER2 IHC Summary can be used to code this data item when no other information is available.

Note 3 The HER2 IHC test performed on the primary breast tissue is to be recorded in this data item.

Note 4 Results from nodal or metastatic tissue may be used, ONLY when there is no evidence of primary tumor.

Note 5 In cases where there are invasive and in situ components and HER2 IHC is done on both, ignore the in situ results.

  • If HER2 IHC is positive on an in situ component and HER2 IHC is negative on all tested invasive components, code HER2 IHC as negative (code 0)
  • If in situ and invasive components present and HER2 IHC only done on the in situ component, code unknown (code 9)

Note 6 In cases where there is a single tumor with multiple biopsies and/or surgical resection with different HER2 IHC results.

  • Use the highest (positive versus negative)

Note 7 In cases where there are multiple tumors with different HER2 IHC results, code the results from the largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

  • Do not use specimen size to determine the largest tumor size

Note 8 If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant therapy.

  • If neoadjuvant therapy is given and there are no HER2 IHC results from pre-treatment specimens, report the findings from post-treatment specimens

Note 9 A 2+ (equivocal) finding by IHC should result in additional testing with ISH to determine gene copy number.

Note 10 An immunohistochemistry (IHC) test identifies the protein expressed by the gene (ERBB2), and an in situ hybridization (ISH) test identifies the number of copies of the gene (ERBB2) itself.

Note 11 HER2 is not routinely done on pure in situ tumors (behavior /2); however, if you have an in situ tumor and there are HER2 results, go ahead and record it. Otherwise code 9.

Code

Description

0

Negative (Score 0)

1

Negative (Score 1+)

2

Equivocal (Score 2+)
Stated as equivocal
Borderline

3

Positive (Score 3+)
Stated as positive

4

Stated as negative, but score not stated

7

Test ordered, results not in chart

8

Not applicable: Information not collected for this case
(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9

Not documented in medical record
Cannot be determined (indeterminate)
HER2 IHC Summary not assessed or unknown if assessed

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N/A-Diagnosis year is after 2020