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    TEST:
    CELsignia test

    Company:
    Celcuity
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    29d
    Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test (clinicaltrials.gov)
    P1/2, N=10, Terminated, M.D. Anderson Cancer Center | Trial completion date: Dec 2028 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2028 --> Nov 2024; Sponsor Withdrew Support
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • Tabrecta (capmatinib)
    1m
    Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test (clinicaltrials.gov)
    P1/2, N=10, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=47 --> 10
    Enrollment closed • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • Tabrecta (capmatinib)
    2ms
    Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling (clinicaltrials.gov)
    P2, N=22, Recruiting, University of Rochester | Trial completion date: Sep 2025 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    CELsignia test
    |
    Nerlynx (neratinib) • capecitabine
    over1year
    HER2-Signal: Fulvestrant + Neratinib In Breast Cancer (clinicaltrials.gov)
    P2; N=25 --> 0 | Trial completion date: Dec 2024 --> Jul 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Enrollment change • Trial withdrawal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • PGR positive
    |
    CELsignia test
    |
    Nerlynx (neratinib) • fulvestrant
    2years
    Trial of Neratinib plus Capecitabine in subjects with HER2-negative metastatic breast cancer with brain metastases and abnormally active HER2 signaling (SABCS 2022)
    Step 1: IC: Abnormal HS; New or progressing BM that is measurable (>5mm); minimum washout periods in wks: last chemotherapy 2, hormonal therapy 1 except fulvestrant 4, targeted therapies 3, eCNS radiation 1, any investigational treatment 4. If 9 or more in the first 12 have died or progressed by 6 wks of treatment, the study will close for futility. PFS and OS will be analyzed using Kaplan-Meier survival functions.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • capecitabine • fulvestrant
    2years
    Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • capecitabine
    over2years
    Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, University of Rochester | Trial completion date: Nov 2023 --> Sep 2025 | Trial primary completion date: Nov 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • capecitabine
    over2years
    Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER2 and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test (clinicaltrials.gov)
    P1/2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • Tabrecta (capmatinib)
    over2years
    Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling (clinicaltrials.gov)
    P2; Initiation date: Apr 2022 --> Jul 2022
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    CELsignia test
    |
    Nerlynx (neratinib) • capecitabine
    almost3years
    Functional signaling test identifies HER2 negative breast cancer patients who may benefit from c-Met and pan-HER combination therapy. (PubMed, Cell Commun Signal)
    The results of this study demonstrated the potential benefit of a functional test for identifying a subpopulation of breast cancer patients with coordinated abnormal HER and c-Met signaling for a clinical trial testing combination targeted therapy. Video Abstract.
    Combination therapy • Journal • Clinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • MET (MET proto-oncogene, receptor tyrosine kinase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 negative
    |
    CELsignia test
    3years
    HER2-Signal: Fulvestrant + Neratinib In Breast Cancer (clinicaltrials.gov)
    P2; Initiation date: Sep 2021 --> Dec 2021
    Trial initiation date • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • PGR positive
    |
    CELsignia test
    |
    Nerlynx (neratinib) • fulvestrant