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Should a borderline negative HER2 result in a core biopsy of invasive carcinoma of the breast have HER2 assessment repeated in the excision specimen?
  1. Andrew H S Lee1,
  2. Zsolt Hodi1,2,
  3. Areeg Abbas1,
  4. Peter Wencyk2,
  5. Ian O Ellis1,2,
  6. Emad Rakha1
  1. 1Histopathology Department, Nottingham University Hospitals NHS Trust, Nottingham, UK
  2. 2Source BioScience plc, Nottingham, UK
  1. Correspondence to Dr Andrew H S Lee, Histopathology Department, Nottingham University Hospitals NHS Trust, Nottingham, UK; andrew.lee{at}


Aim The 2015 UK guidelines for HER2 assessment in breast cancer recommended repeat assessment if the core biopsy was scored as 2+ on HER2 immunohistochemistry (IHC) with borderline negative in situ hybridisation (ratio of number of HER2 to chromosome 17 centromere copies of 1.8–1.99). This case series aimed to assess the value of such repeat assessment in the surgical specimen, in particular the proportion that were HER2 positive.

Methods Details of biopsies with 2+ IHC and borderline negative in situ hybridisation were extracted from a database. The results of repeat HER2 testing in the surgical specimen for this cohort study were then obtained.

Results 112 patients with no preoperative treatment had repeat assessment: 4 were 3+ and 16 were 2+ amplified. Of 14 with preoperative chemotherapy, 1 was 3+ and 4 were 2+ amplified. All the 2+ amplified carcinomas had a HER2 to chromosome 17 ratio less than 4, in 50% the ratio was between 2.0 and 2.2, and in 50% the HER2 copy number was less than 4.

Conclusions Repeat assessment yielded 4% 3+ results and 14% 2+ amplified carcinomas but with low level amplification. These results suggest that retesting of borderline negative HER2 cases should be optional and no longer mandatory.

  • carcinoma
  • breast
  • in situ hybridisation

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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  • Handling editor L C Collins.

  • Contributors AHSL designed the study, wrote the first draft apart from the section on in situ hybridisation by PW, and is the guarantor. All authors contributed to the analysis of the data and revision of later drafts.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.