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Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients (EQUIVOK)

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ClinicalTrials.gov Identifier: NCT03197805
Recruitment Status : Terminated (Take care recommendations for Her2 equivok patients has changed.)
First Posted : June 23, 2017
Last Update Posted : July 25, 2019
Sponsor:
Collaborators:
Roche Pharma AG
NanoString Technologies, Inc.
Information provided by (Responsible Party):
Centre Jean Perrin

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: PAM 50 test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort longitudinal follow up
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Use of PAM 50 test in Her2 equivocal breast cancer patient
Patients with an equivocal-HER2 breast cancer (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio <2 and 4 ≤HER2 gene number copy < 6) will be eligible for RNA genomic test (PAM 50 test).
Diagnostic Test: PAM 50 test
Patients with an equivocal-HER2 breast cancer (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio <2 and 4 ≤HER2 gene number copy < 6) will be eligible for RNA genomic test (PAM 50 test). The use of genomic test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population.




Primary Outcome Measures :
  1. The modification of therapeutical decision between the first and the second multidisciplinary decision-making meeting (MD-MM) using a genomic testing [ Time Frame: The measure will be realised after the second multidisciplinary decision-making meeting that is about one month after patient's inclusion. ]
    Percentage of therapeutical strategy changes between the first and the second multidisciplinary decision-making meetings.


Secondary Outcome Measures :
  1. The HER2 overexpression incidence according to RNA genomic profile among equivocal-HER2 patients [ Time Frame: The measure will be done when the genomic test is realised, that is about three weeks after patient's inclusion. ]
    Percentage of HER2 classified patients using a genomic test among equivocal-HER2 patients

  2. The concordance between the second multidisciplinary decision-making meeting decision and the HER2 genomic test result [ Time Frame: The measure will be done when the genomic test is realised, that is about three weeks after patient's inclusion. ]
    Percentage of second multidisciplinary decision-making meeting decision in accordance with genomic test result and reasons justifying discrepancies (check-list and comments)


Other Outcome Measures:
  1. To compare results from different ISH methods used [ Time Frame: The measure will be done when the genomic test is realised, that is about three weeks after patient's inclusion.. ]
    Comparison between all ISH (FISH, SISH, CISH, or DDISH) methods based upon the HER2-eligible classification (Wolff et al 2013)

  2. The concordance between local and centralized anatomopathologist HER2 status [ Time Frame: The measure will be done when the genomic test is realised,that is about three weeks after patient's inclusion. ]
    Concordance between local and centralized anatomopathologist HER2 status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Performance status ≤ 2 (according to WHO criteria)
  • Patient with early invasive breast cancer histologically confirmed stage I to IIIA)
  • Positive or negative lymph node involvement
  • Positive or negative Hormonal Receptors (Estrogens and/or Progesterone),
  • Equivocal HER2 status (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio <2 and 4 ≤ HER2 gene number copy < 6) as assessed on surgical specimen
  • Adequate Hematological, Hepatic, Renal and Cardiac Functions
  • Patient potentially eligible for an anti-HER2 therapy
  • Patient eligible to receive an adjuvant therapy
  • Signed Informed Consent
  • Patient with social insurance.

Exclusion Criteria:

  • Non-measurable tumor
  • Unknown Hormonal Receptors
  • Unknown node involvement
  • Positive or negative HER2 status (Score 0, 1 or 3 IHC, or Negative or positive ISH)
  • Disease stage ≥IIIB
  • Patient not able to follow the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197805


Locations
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France
CHRU Jean Minoz
Besançon, France, 25030
Institut Bergonie
Bordeaux, France, 33076
Centre François Baclesse
Caen, France, 14000
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Centre Georges François Leclerc
Dijon, France, 21079
CHU Albert Michalon
Grenoble, France, 38043
Hopital DUPUYTREN
Limoges, France, 87042
Centre Léon Bérard
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 13009
Institut de Cancérologie de Montpellier
Montpellier, France, 34298
Institut Jean Godinot
Reims, France, 51056
Institut du Cancer COURLANCY
Reims, France, 51100
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Sponsors and Collaborators
Centre Jean Perrin
Roche Pharma AG
NanoString Technologies, Inc.
Investigators
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Principal Investigator: Marie-Ange MOURET-REYNIER, MD Centre Jean Perrin

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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT03197805    
Other Study ID Numbers: 2017-A00240-53
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Jean Perrin:
Equivocal Her 2
Genomic test
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases