Breast CancerEQUIVOKNCT03197805
Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients
A study testing PAM 50 test in people with Breast Cancer, run by Centre Jean Perrin at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PAM 50 test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 16 sitesFrance
- Study dates
- 16 Oct 2017to 28 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Patient potentially eligible for an anti-HER2 therapy
- Patient eligible to receive an adjuvant therapy
- Signed Informed Consent
- Patient with social insurance.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CHRU Jean Minoz
Besançon, 25030
Institut Bergonie
Bordeaux, 33076
Centre François Baclesse
Caen, 14000
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Georges François Leclerc
Dijon, 21079
CHU Albert Michalon
Grenoble, 38043
Hopital DUPUYTREN
Limoges, 87042
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13009
Institut de Cancérologie de Montpellier
Montpellier, 34298
Institut Jean Godinot
Reims, 51056
Institut du Cancer COURLANCY
Reims, 51100
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- PAM 50 test
- Keywords
- Equivocal Her 2, Genomic test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAM 50 testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Use of PAM 50 test in Her2 equivocal breast cancer patient | Experimental | 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). Receives: Diagnostic Test: PAM 50 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modification of therapeutical decision between the first and the second multidisciplinary decision-making meeting (MD-MM) using a genomic testing
Percentage of therapeutical strategy changes between the first and the second multidisciplinary decision-making meetings.
Measured: The measure will be realised after the second multidisciplinary decision-making meeting that is about one month after patient's inclusion.
Secondary outcomes (2)
The HER2 overexpression incidence according to RNA genomic profile among equivocal-HER2 patients
Percentage of HER2 classified patients using a genomic test among equivocal-HER2 patients
Measured: The measure will be done when the genomic test is realised, that is about three weeks after patient's inclusion.
The concordance between the second multidisciplinary decision-making meeting decision and the HER2 genomic test result
Percentage of second multidisciplinary decision-making meeting decision in accordance with genomic test result and reasons justifying discrepancies (check-list and comments)
Measured: The measure will be done when the genomic test is realised, that is about three weeks after patient's inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start16 Oct 2017
- Primary completion28 May 2019
- Study completion28 May 2019
Why it stopped: Take care recommendations for Her2 equivok patients has changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort longitudinal follow up
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, NanoString Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Marie-Ange MOURET-REYNIER, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197805
- Sponsor's protocol ID
- 2017-A00240-53
- Acronym
- EQUIVOK
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2017
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03197805
- Acronym / sponsor ID
- EQUIVOK / 2017-A00240-53
- Conditions
- Breast Cancer
- Keywords
- Equivocal Her 2, Genomic test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Take care recommendations for Her2 equivok patients has changed.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- Roche Pharma AG, NanoString Technologies, Inc.
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort longitudinal follow up
| Arm | Type | Receives |
|---|---|---|
| Use of PAM 50 test in Her2 equivocal breast cancer patient | Experimental | Diagnostic Test: PAM 50 testPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAM 50 testPatients 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. | Diagnostic test | Use of PAM 50 test in Her2 equivocal breast cancer patient |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study was stopped early (reason given: Take care recommendations for Her2 equivok patients has changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Ange MOURET-REYNIER, MD principal investigator
Centre Jean Perrin
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAM 50 test in people with Breast Cancer, run by Centre Jean Perrin at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Take care recommendations for Her2 equivok patients has changed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.