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TEST:
CELsignia test

Company:
Celcuity
Type:
Laboratory Developed Test
Evidence

News

8ms
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 Withdrawn | Trial primary completion date: Dec 2023 --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
over1year
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
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
CELsignia test
|
Nerlynx (neratinib) • capecitabine • fulvestrant
over1year
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative
|
CELsignia test
|
Nerlynx (neratinib) • capecitabine
over1year
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
over1year
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)
almost2years
Trial initiation date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative
|
CELsignia test
|
Nerlynx (neratinib) • capecitabine
2years
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
over2years
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