ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023
Biomarker Data from the Phase III KATHERINE Study of Adjuvant T-DM1 versus Trastuzumab for Residual Invasive Disease after Neoadjuvant Therapy for HER2-Positive Breast Cancer.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
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Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Efficacy of dual HER2 blockade in neoadjuvant HER2-positive breast cancer: a meta-analysis of RCTs.Systematic reviews · 2026Pooled it
- Switching to T-DM1 remains justified in patients with HER2-negative residual invasive breast cancer after neoadjuvant therapy.Breast (Edinburgh, Scotland) · 2025Trial
- Impact of somatic PIK3CA mutations on clinical outcomes in HER2-positive breast cancer.Breast cancer research : BCR · 2026Article
- HER2 intratumoral heterogeneity predicts response to neoadjuvant therapy in HER2-positive breast cancer: impact and interplay with HER3 expression.Virchows Archiv : an international journal of pathology · 2026Article
- Tumor mutations predict HER2-targeted therapy resistance in primary HER2-positive breast cancer.NPJ breast cancer · 2026Article
- Immune profiling in residual disease: refining risk stratification after neoadjuvant therapy in HER2-positive breast cancer.Translational cancer research · 2026Article
- Predictive Biomarkers of Antibody-Drug Conjugate Efficacy for Solid Tumors: Current Challenges and the Potential Role of Quantitative Proteomics.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- Clinical outcomes and genomic landscape of anti-HER2 antibody-drug conjugates in HER2-positive and HER2-low metastatic breast cancer.Therapeutic advances in medical oncology · 2026Article
- Endocrine therapy resistance of breast cancer: Important role of G protein-coupled estrogen receptor (GPER) and new therapeutic strategies.Genes & diseases · 2026Review
- HER2 expression in breast cancer: evidence gaps and challenges.NPJ precision oncology · 2025Review
- Neoadjuvant Regimens and Their Impact on Adjuvant T-DM1 Outcomes in HER2-Positive Early Breast Cancer.Medicina (Kaunas, Lithuania) · 2025Article
- Digitally quantified area of residual tumor after neoadjuvant chemotherapy in HER2-positive breast cancer.Breast cancer (Tokyo, Japan) · 2025Article
- Impact of HER2 Status Assessed by Immunohistochemistry on Treatment Response in Patients with Metastatic Breast Cancer Receiving Trastuzumab Emtansine.Medicina (Kaunas, Lithuania) · 2025Article
- SNX10 deficiency impairs sensitivity to anti-HER2 antibody-drug conjugates via altering HER2 trafficking in HER2-positive breast cancer.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Prognostic value of residual disease (RD) biology and gene expression changes during the neoadjuvant treatment in patients with HER2-positive early breast cancer (EBC).Annals of oncology : official journal of the European Society for Medical Oncology · 2025Article
- Assessment of targets of antibody drug conjugates in SCLC.NPJ precision oncology · 2025Article
- The interplay between the immune response and neoadjuvant therapy in breast cancer.Frontiers in oncology · 2025Review
- HER2-positive gastric cancer: from targeted therapy to CAR-T cell therapy.Frontiers in immunology · 2025Review
- Article
- Targeting TACC3 Induces Immunogenic Cell Death and Enhances T-DM1 Response in HER2-Positive Breast Cancer.Cancer research · 2024Article
Corrections and comments
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Authors and funding
18 authors at 12 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn KATHERINE, adjuvant T-DM1 reduced risk of disease recurrence or death by 50% compared with trastuzumab in patients with residual invasive breast cancer after neoadjuvant therapy (NAT) comprised of HER2-targeted therapy and chemotherapy. This analysis aimed to identify biomarkers of response and differences in biomarker expression before and after NAT. EXPERIMENTAL
designExploratory analyses investigated the relationship between invasive disease-free survival (IDFS) and HER2 protein expression/gene amplification, PIK3CA hotspot mutations, and gene expression of HER2, PD-L1, CD8, predefined immune signatures, and Prediction Analysis of Microarray 50 intrinsic molecular subtypes, classified by Absolute Intrinsic Molecular Subtyping. HER2 expression on paired pre- and post-NAT samples was examined.
resultsT-DM1 appeared to improve IDFS versus trastuzumab across most biomarker subgroups, except the HER2 focal expression subgroup. High versus low HER2 gene expression in residual disease was associated with worse outcomes with trastuzumab [HR, 2.02; 95% confidence interval (CI), 1.32-3.11], but IDFS with T-DM1 was independent of HER2 expression level (HR, 1.01; 95% CI, 0.56-1.83). Low PD-L1 gene expression in residual disease was associated with worse outcomes with trastuzumab (HR, 0.66; 95% CI, 0.44-1.00), but not T-DM1 (HR, 1.05; 95% CI, 0.59-1.87). PIK3CA mutations were not prognostic. Increased variability in HER2 expression was observed in post-NAT versus paired pre-NAT samples.
conclusionsT-DM1 appears to overcome HER2 resistance. T-DM1 benefit does not appear dependent on immune activation, but these results do not rule out an influence of the tumor immune microenvironment on the degree of response.
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