^
    3d
    LEEWARD: A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors (clinicaltrials.gov)
    P=N/A, N=750, Completed, Novartis Pharmaceuticals
    New trial • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict®
    6d
    MCLAM: a cost-effective deep learning model for predicting recurrence risk in HR+/HER2- breast cancer-a multi-center study in a Chinese cohort. (PubMed, J Natl Cancer Cent)
    To our knowledge, this is the first and largest multi-center study validating an EndoPredict-predicting model in a Chinese HR+/HER2- breast cancer cohort, addressing a key population gap. MCLAM provides an accurate, interpretable, and cost-efficient alternative to molecular assays, enabling accessible individualized risk assessment and supporting personalized treatment strategies.
    Journal • HEOR • Cost-effectiveness
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
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    EndoPredict®
    1m
    RIBOLARIS: Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=1100, Active, not recruiting, SOLTI Breast Cancer Research Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    |
    docetaxel • doxorubicin hydrochloride • cyclophosphamide • Kisqali (ribociclib)
    1m
    Node properties of biomarkers within the protein-protein interaction network derived from breast cancer-associated genes. (PubMed, PLoS One)
    Collectively, our findings indicate that many effective BC biomarkers are components of large, evolutionarily conserved cliques within cell-cycle-associated regions of the PPI network. Finally, based on this MCC-centric approach, we identified 11 novel candidate biomarkers.
    Journal
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    2ms
    Advances in Breast Cancer Diagnostics: From Screening to Precision Medicine. (PubMed, Diagnostics (Basel))
    Precision diagnostics now encompass next-generation sequencing (NGS)-based comprehensive genomic profiling, enabling identification of actionable alterations such as PIK3CA mutations, HER2 amplification, BRCA1/2 pathogenic variants, and NTRK fusions, each linked to approved therapeutic agents. The purpose of this review is to provide a comprehensive synthesis of current and emerging diagnostic modalities in breast cancer-from population-level screening to individualized molecular profiling-and to examine how integrative, multimodal diagnostic platforms are reshaping clinical decision-making in the era of precision medicine.
    Review • Journal • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 amplification • PIK3CA mutation • HER-2 amplification + HR-positive • NTRK fusion
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    2ms
    the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer (clinicaltrials.gov)
    P2, N=94, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib)
    2ms
    Multigene assays in early breast cancer: Current evidence, limits and future directions. (PubMed, Cancer Treat Rev)
    The evolution of genomic assays, including Oncotype DX®, MammaPrint®, Prosigna®, EndoPredict®, and Breast Cancer Index®, along with the collaboration of multidisciplinary teams, signifies a transition toward more customized and effective therapeutic strategies. Our work offers a thorough overview of the advancing strategies in breast cancer management in terms of multigene assay application to the clinical routine, specifically focusing on current evidence, limits and future research directions.
    Review • Journal
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • Breast Cancer Index® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    3ms
    The Impact of Clinical and Demographic Factors on High-Risk Patient Classification Frequencies by the EndoPredict Test: A Review and Single-Site Study. (PubMed, Cancers (Basel))
    Variability in EndoPredict risk classification reflects both tumor biological features and population-specific factors. These findings emphasize the importance of interpreting genomic risk scores within their clinical and demographic context and support the comparison of risk distributions across heterogeneous patient cohorts.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    EndoPredict®
    3ms
    A machine learning assay to predict disease recurrence in hormone receptor-positive breast cancer. (PubMed, ESMO Open)
    ER-Predict represents a robust assay with potential utility in early stage HR-positive/HER2-negative breast cancer. Its consistent ability to identify high-risk patients supports further investigation as a decision-support tool to guide treatment intensification in clinically low-risk HR-positive/HER2-negative disease.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • RB1 (RB Transcriptional Corepressor 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    3ms
    OBU-BC-II-164: Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=100, Enrolling by invitation, Peking University | Not yet recruiting --> Enrolling by invitation
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    EndoPredict®
    |
    letrozole • AiRuiKang (dalpiciclib)
    3ms
    SiMoSein: Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P=N/A, N=1000, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 amplification + HR-positive
    |
    EndoPredict®
    4ms
    NATALEE: A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (clinicaltrials.gov)
    P3, N=5101, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2026 --> May 2030 | Trial primary completion date: May 2026 --> May 2030
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint® • EndoPredict®
    |
    Kisqali (ribociclib)