HER2 Positive Breast Cancer - neratinib - HER-2 amplification

Association details:

Biomarker:	HER-2 amplification
Cancer:	HER2 Positive Breast Cancer
Drug:	Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: A1 - Approval

Source:

Knight Therapeutics Press Release

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...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

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NCT03377387

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NCT04366713

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NEAR

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NCT05491057

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

Title:

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Excerpt:

...Phase I HER2-amplified Cohort...

Trial ID:

NCT01111825

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NCT00741260

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2007-007885-39

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2008-001662-85

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2008-005425-11

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2019-001896-35

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2008-007803-10

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

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:

2006-006412-29

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

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:

NCT03289039