Neratinib was recently approved by the FDA for extended adjuvant treatment of HER2 breast cancer. The ExteNET trial showed improvement in invasive disease-free survival (iDFS) in the neratinib arm compared with placebo. The benefit was more pronounced in patients with estrogen receptor-positive (ER)/HER2 tumors, suggesting bidirectional cross-talk between the ER and HER pathways. .
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Clinicopathological and molecular features of HR /HER2 breast cancer patients with distinct endocrine resistance patterns.
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The immunohistochemical (IHC) or fluorescence/chromogenic in situ hybridization (FISH/CISH) assays for assessing HER2 are now recommended by the American Society of Clinical Oncologists and the College of American Pathologists, but there are an increasing number of published studies describing alternative diagnoses at the molecular level. Inspired by these studies, we established a laboratory-developed test (LDT) to analyze status not only at the gene expression level but also at the gene copy number. A precise copy number calculation was fulfilled including the Control Genomic DNA of known concentration, which allowed subsequent assay validation at the DNA level.
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Guidelines for the first-line treatment of Hormone Receptor-positive, HER2-negative advanced or recurrent breast cancer have shifted to combination therapies of a CDK4/6 inhibitor and endocrine therapy. However, determining an optimal subsequent therapy following CDK4/6 inhibitor progression remains challenging, especially for tumors lacking actionable mutations. Real-world data suggest that fulvestrant monotherapy is frequently selected in this post-CDK4/6 inhibitor setting.
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