Biomarkers in breast cancer 2024 - an updated consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology

Sep 22, 2026

Revised consensus guidance from the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathological Anatomy (SEAP) updates recommendations for using biomarkers in breast cancer for diagnosis and treatment beyond the 2018 statement. The expert group advises testing early breast cancer for ER, PR, Ki-67, and HER2, plus BRCA genes in high-risk HER2-negative disease. It also covers genetic prognostic platforms in ER-positive cases to guide adjuvant therapy decisions and recommends additional markers in advanced settings, while noting newer technologies remain investigational.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages17

Reading Time43 min

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Abstract

Introduction

Early-stage breast cancer

Histological type and grade

Clinical and Translational Oncology (2024) 26:2935–2951 [https://doi.org/10.1007/s12094-024-03541-1](https://doi.org/10.1007/s12094-024-03541-1) Biomarkers in breast cancer 2024: an updated consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology Ramon Colomer1 · Blanca González‑Farré2 · Ana Isabel Ballesteros3 · Vicente Peg4 · Begoña Bermejo5 · Belén Pérez‑Mies6 · Susana de la Cruz7 · Federico Rojo8 · Sonia Pernas9 · José Palacios10 Received: 23 May 2024 / Accepted: 25 May 2024 / Published online: 13 June 2024 © The Author(s) 2024 Abstract This revised consensus statement of the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathological Anatomy (SEAP) updates the recommendations for biomarkers use in the diagnosis and treatment of breast cancer that we first published in 2018. The expert group recommends determining in early breast cancer the estrogen receptor (ER), progesterone receptor (PR), Ki-67, and Human Epidermal growth factor Receptor 2 (HER2), as well as BReast CAncer (BRCA) genes in high-risk HER2-negative breast cancer, to assist prognosis and help in indicating the therapeutic options, including hormone therapy, chemotherapy, anti-HER2 therapy, and other targeted therapies. One of the four available genetic prognostic platforms (Oncotype DX®, MammaPrint®, Prosigna®, or EndoPredict®) may be used in ER-positive patients with early breast cancer to establish a prognostic category and help decide with the patient whether adjuvant treatment maybe limited to hormonal therapy. In second-line advanced breast cancer, in addition, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) and estrogen receptor 1 (ESR1) should be tested in hormone-sensitive cases, BRCA gene mutations in HER2-negative cancers, and in triple-negative breast cancer (TNBC), programmed cell death-1 ligand (PD-L1). Newer biomarkers and technologies, including tumor-infiltrating lymphocytes (TILs), homologous recombination deficiency (HRD) testing, serine/threonine kinase (AKT) pathway activation, and next-generation sequencing (NGS), are at this point investigational. Keywords Breast neoplasm · Diagnostic · Gene expression profiling · Prognostic · Therapy predictive Introduction Biomarker analysis in cancer provides information that complements classical clinical factors, and also enables certain treatments in patients to be selected [1] . In breast cancer, biomarker analysis began with testing for hormone receptor expression to guide tamoxifen therapy. The subsequent inclusion of targeted treatments against human epidermal growth factor receptor 2 (HER2) revolutionized the biomarker field. It also highlighted that biomarker test methods need to be standardized and harmonized. The intervening Ramon Colomer, Ana Isabel Ballesteros, Begoña Bermejo, Susana de la Cruz, and Sonia Pernas are experts from the Spanish Society of Medical Oncology (SEOM); and Blanca González-Farré, Vicente Peg, Belén Pérez-Mies, Federico Rojo, and José Palacios are experts from the Spanish Society of Pathological Anatomy (SEAP) . Extended author information available on the last page of the article years have also seen progress in the understanding of single molecular abnormalities in breast cancer related to specific molecular therapies, such as BReast CAncer (BRCA) gene, programmed cell death-1 ligand (PD-L1), phosphatidylinositol 3-kinase (PI3K), or estrogen receptor 1 (ESR1) . The clinical potential for monitoring disease using new technologies grouped under the term liquid biopsy is currently being studied. The purpose of these revised consensus guidelines from the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathological Anatomy (SEAP) is to recommend which biomarkers should routinely be tested inpatients with breast cancer; including conventional markers, genetic platforms, and newer technologies, as well as those that remain inve

FAQs

Which biomarkers does the consensus recommend testing in early breast cancer?

In early breast cancer, the expert group recommends determining ER, PR, Ki-67, and HER2, and testing BRCA genes in high-risk HER2-negative breast cancer.

How are genetic prognostic platforms used in ER-positive early breast cancer?

One of Oncotype DX, MammaPrint, Prosigna, or EndoPredict may be used in ER-positive early breast cancer to establish a prognostic category and help decide whether adjuvant treatment may be limited to hormonal therapy.

What additional biomarkers are recommended for second-line advanced breast cancer?

For second-line advanced cases, PIK3CA and ESR1 should be tested in hormone-sensitive disease; BRCA gene mutations are recommended in HER2-negative cancers; and PD-L1 is recommended in triple-negative breast cancer.

Sep 22, 2026

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