ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34

Stephanie Kacerovsky-Strobl; Christine Deutschmann; Dominik Hlauschek; Zsuzsanna Bago-Horvath; Christian F Singer; Rupert Bartsch; Richard Greil; Karl Sotlar; Gabriel Rinnerthaler; Edgar Petru; Sigurd F Lax; Daniel Egle; Angelika Pichler; Koppány Bodó; Andreas L Petzer; Farid Moinfar; Jodi Weidler; Michael Bates; Peter Dubsky; Michael Gnant; Martin Filipits

doi:10.1016/j.breast.2025.104633

ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34

Stephanie Kacerovsky-Strobl
, Christine Deutschmann
, Dominik Hlauschek
, Zsuzsanna Bago-Horvath
, Christian F Singer
, Rupert Bartsch
, Richard Greil
, Karl Sotlar
, Gabriel Rinnerthaler
, Edgar Petru
, Sigurd F Lax
, Daniel Egle
, Angelika Pichler
, Koppány Bodó
, Andreas L Petzer
, Farid Moinfar
, Jodi Weidler
, Michael Bates
, Peter Dubsky
, Michael Gnant

Martin Filipits^*

^*Corresponding author for this work

Department of Pathology and Molecular Pathology

Research output: Contribution to journal › Article › peer-review

Abstract

AIM: To investigate the performance of the Xpert® Breast Cancer STRAT4 (CE-IVD∗) Assay (STRAT4) in the neoadjuvant, randomized Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 34.

PATIENTS AND METHODS: The primary objective of this study was to assess the concordance between STRAT4 mRNA measurements of ESR1, PGR, ERBB2, and MKi67 obtained from diagnostic core biopsies of the ABCSG Trial 34 with central reference laboratory immunohistochemistry (IHC) (and in-situ hybridization for HER2 IHC 2+ samples). For each marker, overall percent agreement (concordance), positive percent agreement (sensitivity), and negative percent agreement (specificity) between STRAT4 and IHC were determined. The secondary objective was to evaluate the concordance of STRAT 4 and IHC in post-treatment surgical samples and the association of both assays with residual cancer burden (RCB), time to distant recurrence (DR), and overall survival (OS). Logistic regression and Cox regression models were used.

RESULTS: A total of 354 formalin-fixed paraffin-embedded diagnostic core biopsies were examined, representing 88.5 % of the available samples. Concordance between STRAT 4 and IHC was 93.7 % for ER, 80.5 % for PR, and 94.1 % for Ki67. All three biomarkers tested by either STRAT4 or central IHC showed similar correlation to RCB, time to DR, and OS.

CONCLUSIONS: In diagnostic core biopsies, there was a good agreement between STRAT4 mRNA measurements and centrally assessed IHC measurements of ER, and moderate agreement for PR and Ki67.

Original language	English
Article number	104633
Journal	The Breast
Volume	84
DOIs	https://doi.org/10.1016/j.breast.2025.104633
Publication status	Published - Dec 2025

Fields of science

301108 Molecular pathology
301101 General pathology

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10.1016/j.breast.2025.104633

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Kacerovsky-Strobl, S., Deutschmann, C., Hlauschek, D., Bago-Horvath, Z., Singer, C. F., Bartsch, R., Greil, R., Sotlar, K., Rinnerthaler, G., Petru, E., Lax, S. F., Egle, D., Pichler, A., Bodó, K., Petzer, A. L., Moinfar, F., Weidler, J., Bates, M., Dubsky, P., ... Filipits, M. (2025). ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34. The Breast, 84, Article 104633. https://doi.org/10.1016/j.breast.2025.104633

@article{2dac426adbf146318176edb2dc9f89e9,

title = "ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34",

abstract = "AIM: To investigate the performance of the Xpert{\textregistered} Breast Cancer STRAT4 (CE-IVD∗) Assay (STRAT4) in the neoadjuvant, randomized Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 34.PATIENTS AND METHODS: The primary objective of this study was to assess the concordance between STRAT4 mRNA measurements of ESR1, PGR, ERBB2, and MKi67 obtained from diagnostic core biopsies of the ABCSG Trial 34 with central reference laboratory immunohistochemistry (IHC) (and in-situ hybridization for HER2 IHC 2+ samples). For each marker, overall percent agreement (concordance), positive percent agreement (sensitivity), and negative percent agreement (specificity) between STRAT4 and IHC were determined. The secondary objective was to evaluate the concordance of STRAT 4 and IHC in post-treatment surgical samples and the association of both assays with residual cancer burden (RCB), time to distant recurrence (DR), and overall survival (OS). Logistic regression and Cox regression models were used.RESULTS: A total of 354 formalin-fixed paraffin-embedded diagnostic core biopsies were examined, representing 88.5 \% of the available samples. Concordance between STRAT 4 and IHC was 93.7 \% for ER, 80.5 \% for PR, and 94.1 \% for Ki67. All three biomarkers tested by either STRAT4 or central IHC showed similar correlation to RCB, time to DR, and OS.CONCLUSIONS: In diagnostic core biopsies, there was a good agreement between STRAT4 mRNA measurements and centrally assessed IHC measurements of ER, and moderate agreement for PR and Ki67.",

keywords = "Humans, Female, Breast Neoplasms/pathology, Receptor, ErbB-2/genetics, RNA, Messenger/metabolism, Ki-67 Antigen/genetics, Estrogen Receptor alpha/genetics, Middle Aged, Biomarkers, Tumor/metabolism, Receptors, Progesterone/genetics, Immunohistochemistry, Adult, Aged, Biopsy, Large-Core Needle",

author = "Stephanie Kacerovsky-Strobl and Christine Deutschmann and Dominik Hlauschek and Zsuzsanna Bago-Horvath and Singer, \{Christian F\} and Rupert Bartsch and Richard Greil and Karl Sotlar and Gabriel Rinnerthaler and Edgar Petru and Lax, \{Sigurd F\} and Daniel Egle and Angelika Pichler and Kopp{\'a}ny Bod{\'o} and Petzer, \{Andreas L\} and Farid Moinfar and Jodi Weidler and Michael Bates and Peter Dubsky and Michael Gnant and Martin Filipits",

year = "2025",

month = dec,

doi = "10.1016/j.breast.2025.104633",

language = "English",

volume = "84",

journal = "The Breast",

issn = "1532-3080",

}

Kacerovsky-Strobl, S, Deutschmann, C, Hlauschek, D, Bago-Horvath, Z, Singer, CF, Bartsch, R, Greil, R, Sotlar, K, Rinnerthaler, G, Petru, E, Lax, SF, Egle, D, Pichler, A, Bodó, K, Petzer, AL, Moinfar, F, Weidler, J, Bates, M, Dubsky, P, Gnant, M & Filipits, M 2025, 'ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34', The Breast, vol. 84, 104633. https://doi.org/10.1016/j.breast.2025.104633

TY - JOUR

T1 - ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34

AU - Kacerovsky-Strobl, Stephanie

AU - Deutschmann, Christine

AU - Hlauschek, Dominik

AU - Bago-Horvath, Zsuzsanna

AU - Singer, Christian F

AU - Bartsch, Rupert

AU - Greil, Richard

AU - Sotlar, Karl

AU - Rinnerthaler, Gabriel

AU - Petru, Edgar

AU - Lax, Sigurd F

AU - Egle, Daniel

AU - Pichler, Angelika

AU - Bodó, Koppány

AU - Petzer, Andreas L

AU - Moinfar, Farid

AU - Weidler, Jodi

AU - Bates, Michael

AU - Dubsky, Peter

AU - Gnant, Michael

AU - Filipits, Martin

PY - 2025/12

Y1 - 2025/12

N2 - AIM: To investigate the performance of the Xpert® Breast Cancer STRAT4 (CE-IVD∗) Assay (STRAT4) in the neoadjuvant, randomized Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 34.PATIENTS AND METHODS: The primary objective of this study was to assess the concordance between STRAT4 mRNA measurements of ESR1, PGR, ERBB2, and MKi67 obtained from diagnostic core biopsies of the ABCSG Trial 34 with central reference laboratory immunohistochemistry (IHC) (and in-situ hybridization for HER2 IHC 2+ samples). For each marker, overall percent agreement (concordance), positive percent agreement (sensitivity), and negative percent agreement (specificity) between STRAT4 and IHC were determined. The secondary objective was to evaluate the concordance of STRAT 4 and IHC in post-treatment surgical samples and the association of both assays with residual cancer burden (RCB), time to distant recurrence (DR), and overall survival (OS). Logistic regression and Cox regression models were used.RESULTS: A total of 354 formalin-fixed paraffin-embedded diagnostic core biopsies were examined, representing 88.5 % of the available samples. Concordance between STRAT 4 and IHC was 93.7 % for ER, 80.5 % for PR, and 94.1 % for Ki67. All three biomarkers tested by either STRAT4 or central IHC showed similar correlation to RCB, time to DR, and OS.CONCLUSIONS: In diagnostic core biopsies, there was a good agreement between STRAT4 mRNA measurements and centrally assessed IHC measurements of ER, and moderate agreement for PR and Ki67.

AB - AIM: To investigate the performance of the Xpert® Breast Cancer STRAT4 (CE-IVD∗) Assay (STRAT4) in the neoadjuvant, randomized Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 34.PATIENTS AND METHODS: The primary objective of this study was to assess the concordance between STRAT4 mRNA measurements of ESR1, PGR, ERBB2, and MKi67 obtained from diagnostic core biopsies of the ABCSG Trial 34 with central reference laboratory immunohistochemistry (IHC) (and in-situ hybridization for HER2 IHC 2+ samples). For each marker, overall percent agreement (concordance), positive percent agreement (sensitivity), and negative percent agreement (specificity) between STRAT4 and IHC were determined. The secondary objective was to evaluate the concordance of STRAT 4 and IHC in post-treatment surgical samples and the association of both assays with residual cancer burden (RCB), time to distant recurrence (DR), and overall survival (OS). Logistic regression and Cox regression models were used.RESULTS: A total of 354 formalin-fixed paraffin-embedded diagnostic core biopsies were examined, representing 88.5 % of the available samples. Concordance between STRAT 4 and IHC was 93.7 % for ER, 80.5 % for PR, and 94.1 % for Ki67. All three biomarkers tested by either STRAT4 or central IHC showed similar correlation to RCB, time to DR, and OS.CONCLUSIONS: In diagnostic core biopsies, there was a good agreement between STRAT4 mRNA measurements and centrally assessed IHC measurements of ER, and moderate agreement for PR and Ki67.

KW - Humans

KW - Female

KW - Breast Neoplasms/pathology

KW - Receptor, ErbB-2/genetics

KW - RNA, Messenger/metabolism

KW - Ki-67 Antigen/genetics

KW - Estrogen Receptor alpha/genetics

KW - Middle Aged

KW - Biomarkers, Tumor/metabolism

KW - Receptors, Progesterone/genetics

KW - Immunohistochemistry

KW - Adult

KW - Aged

KW - Biopsy, Large-Core Needle

UR - https://www.scopus.com/pages/publications/105020783582

U2 - 10.1016/j.breast.2025.104633

DO - 10.1016/j.breast.2025.104633

M3 - Article

C2 - 41197528

SN - 1532-3080

VL - 84

JO - The Breast

JF - The Breast

M1 - 104633

ER -

ESR1, PGR, ERBB2, and MKi67 mRNA expression in diagnostic core biopsies from breast cancer patients of the ABCSG Trial 34

Abstract

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