Breast Cancer Clinical Trial
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
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.
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