^
    2d
    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®
    2d
    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
    12d
    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)
    16d
    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®
    26d
    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 Cancer Prognostic Gene Signature Assay • MammaPrint® • EndoPredict®
    |
    Kisqali (ribociclib)
    2ms
    PRELUDE: A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing (clinicaltrials.gov)
    P=N/A, N=2000, Recruiting, National and Kapodistrian University of Athens
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    EndoPredict®
    2ms
    SiMoSein: Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P=N/A, N=1000, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 amplification + HR-positive
    |
    EndoPredict®
    2ms
    the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer (clinicaltrials.gov)
    P2, N=94, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib)
    3ms
    Longitudinal multiomics analysis of endocrine therapy effects and gut microbiota in breast cancer recurrence. (PubMed, Commun Med (Lond))
    This study provides the first human evidence with long-term ET administration to reveal that, besides genetic profiles, the gut microbiota is another critical factor that we should consider in the influence and prediction of breast cancer recurrence in the future.
    Journal
    |
    EndoPredict®
    |
    tamoxifen • letrozole
    3ms
    Guestimating Molecular Subtyping of Breast Cancer by Ki67 in the Era of Artificial Intelligence. (PubMed, Int J Breast Cancer)
    Our data provides a snapshot of the real-world allocation of multigene testing in early breast cancer, and supports other studies in highlighting the discrepancy between IHC-based and gene-based luminal subtyping. Ki67 evaluation remained consistent over time, and the use of AI for Ki67 scoring did not enhance the accuracy of IHC-based luminal subtyping.
    Journal
    |
    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
    |
    EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    6ms
    Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node-positive early breast cancer: a systematic review and economic evaluation. (PubMed, Health Technol Assess)
    49. See the NIHR Funding and Awards website for further award information.
    Review • Journal • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint® • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    6ms
    DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE) (clinicaltrials.gov)
    P2, N=70, Recruiting, Criterium, Inc. | Trial completion date: Dec 2027 --> Dec 2028
    Trial completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • ER negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint® • Signatera™ • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
    |
    Ibrance (palbociclib) • fulvestrant