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Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer
Published date:
07/06/2021
Excerpt:
Knight Therapeutics Inc. (TSX: GUD), ("Knight")...announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting....The approval was based on results of the global Phase III NALA trial.
Secondary therapy:
capecitabine
Source:
Title:
1O - Neratinib + capecitabine vs lapatinib + capecitabine in HER2+ metastatic breast cancer previously treated with ≥2 HER2-directed regimens: Exploratory biomarker analyses from phase III NALA trial
Published date:
05/23/2020
Excerpt:
Pts whose tumors had higher HER2 protein expression evaluated by any of the three methods appeared to have derived consistent benefit from N+C vs L+C (HER2 IHC3+: HR=0.64, CI 0.51–0.81, p<0.001; H-score ≥median (240): HR=0.54, CI 0.41–0.72, p<0.001; HERmark positive: HR=0.65, CI 0.50– 0.84, p<0.001)....Higher HER2 protein expression associates with increased PFS in the overall study population, and a greater benefit from N+C vs. L+C.
Secondary therapy:
capecitabine
Trial ID:
Source:
Title:
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
Excerpt:
...- Documented HER2 overexpression (immunohistochemistry (IHC) 3+ or gene-amplified tumor with fluorescence in situ hybridization (FISH) ratio of ≥ 2.0....
Trial ID:
Source:
Title:
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
Excerpt:
...- Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology...
Trial ID:
More C2 evidence
Source:
Title:
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
Excerpt:
...Documented HER2 overexpression or gene-amplified tumor by a validated approved method....
Trial ID:
Source:
Title:
Treatment Patterns of Neratinib in HER2+ EBC in China
Excerpt:
...- Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease....
Trial ID:
Source:
Title:
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Excerpt:
...- HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridisation (FISH) (≥2.0)...
Trial ID:
Source:
Title:
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
Excerpt:
...- erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1....
Trial ID:
Source:
Title:
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancer
Excerpt:
...Documentation of erbB-2 gene amplification by FISH (as defined by a ratio >2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory or initial diagnostic results utilizing one of the sponsor-approved assays. ...
Trial ID:
Source:
Title:
A Clinical Study to Investigate Colon Pathology in Patients With Breast Cancer And HER2 Overexpression When Treated With Neratinib Um estudo clínico para investigar a patologia do cólon em doentes com cancro da mama e sobre-expressão de HER2 quando tratados com Neratinib
Excerpt:
...Documented HER2 overexpression or gene-amplified tumor by a validated approved method. ...
Trial ID:
Source:
Title:
Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or locally advanced Breast Cancer
Excerpt:
...Documentation of erbB-2 status by FISH or erbB-2 overexpression (IHC 3+) based on local testing is accepted. ...
Trial ID:
Source:
Title:
A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
Excerpt:
...For subjects with breast cancer, HER2 gene amplified tumor (FISH) or HER2 overexpression (IHC 3 +). ...
Trial ID:
Source:
Title:
Neratinib adjuvant study
Excerpt:
...Comparison of Disease free survival (DFS) of women with early-stage erbB-2 overexpressed breast cancer following trastuzumab in the adjuvant setting, receiving neratinib against that of women receiving placebo. ...
Trial ID:
Source:
Title:
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
Excerpt:
...Age will be assessed in years = neratinib initiation date - date of birth`Description of age`Gender will be described in percentage of Male and Female among patients`Description of Gender`BMI will be assessed in kg/m2`Description of BMI`Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea`Menopausal status`Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity`Comorbidities`HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)`HER2 overexpression/amplification testing`Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative`Hormone receptor status`Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer`Primary tumor location`Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other`Primary tumor histology`Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated`Histological grade`Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C`Pathologic stage (AJCC classification) of Breast Cancer...
Trial ID:
Source:
Title:
A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer
Excerpt:
...Documentation of erbB-2 gene amplification by fluorescence in situ hybridization (FISH, as defined by a ratio >2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2 overexpression by immunohistochemistry (IHC, defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory or initial diagnostic results utilizing one of the sponsor-approved assays. ...
Trial ID:
