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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
Excerpt:
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.
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:
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:
...Subjects enrolled in Part 2 must have erbB-2 gene amplified tumor. ...
Trial ID:
More C2 evidence
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:
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 2 Study of HKI-272 in Subjects with Advanced Breast Cancer
Excerpt:
...Tumor tissue available and adequate for HER2 gene amplification.4. ...
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:
Source:
Title:
Real-life Pan-HER-blockade With Neratinib
Excerpt:
...- Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;...
Trial ID:
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:
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
Excerpt:
...The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. ...
Trial ID:
Source:
Title:
Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Excerpt:
...- Histologically or cytologically confirmed HER2-negative (0 or 1+ by IHC or non-amplified by FISH) breast cancer that is stage IV....
Trial ID:
Source:
Title:
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
Excerpt:
...- Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +....
Trial ID:
Source:
Title:
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Excerpt:
...Phase I HER2-amplified Cohort...
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:
Neratinib in combination with vinorelbine in metastatic breast cancer patients
Excerpt:
...erbB-2 gene amplified tumor detected by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) (part 2 only). ...
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:
Less C2 evidence
Source:
Title:
Comparative analysis of drug response and gene profiling of HER2-targeted tyrosine kinase inhibitors
Published date:
01/21/2021
Excerpt:
In this study, the anti-proliferative effects of the three TKIs were directly compared using a 115 cancer cell line panel….All three TKIs were effective against HER2-amplified breast cancer models; neratinib showing the most potent activity, followed by tucatinib then lapatinib.
DOI:
10.1038/s41416-020-01257-x
