Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197805
Status:
TERMINATED
Last Update Posted:
2019-07-25
First Post:
2017-06-19
Brief Title:
Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients
Sponsor:
Centre Jean Perrin
Organization:
Centre Jean Perrin
Study Overview
Official Title:
Prospective Study Assessing the Impact of RNA Genomic Profile Defined by a Genomic Test on Treatment Decision-making in Breast Cancer Patients With an ISH Equivocal HER2 Status- EQUIVOK Study
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Take care recommendations for Her2 equivok patients has changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EQUIVOK
Brief Summary:
The American Society of Clinical Oncology ASCO and the College of American Pathologists CAP recommend that HER2 status negative or positive must be determined in all patients with invasive breast cancer The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients Presently two main methods are used to assess HER2 status immunohistochemistry IHC protein expression and in situ hybridization ISH gene expression in order to classify tumor sample as positive negative or equivocal When a tumor is classified HER 2 by IHC method a second test is performed using ISH methods FISH SISH CISH In case of HER2 equivocal result with ISH method 4 HER2 gene number copy 6 the patient is eligible to an anti-HER2 therapy after discussed during MD-MM This decision should be individualized on the basis of patient status comorbidities and prognosis and patient preferences after discussing available clinical evidence
Based on molecular classification RNA expression could help to discriminate breast cancer subtypes luminal A luminal B HER2-overexpressed and triple negative Prosigna is a genomic test developed by NanoString based on the PAM50 gene signature which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status
This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population In addition concordance tests will be performed The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing
Based on molecular classification RNA expression could help to discriminate breast cancer subtypes luminal A luminal B HER2-overexpressed and triple negative Prosigna is a genomic test developed by NanoString based on the PAM50 gene signature which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status
This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population In addition concordance tests will be performed The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None