Breast CancerADENDOMNCT02773004
Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
A study testing EPClin genomic test in people with Breast Cancer, run by UNICANCER.
Trial summary
The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EPClin genomic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Performance status 0 or 1,
- Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer
- Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery
- Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation
- ER-positive by IHC (>10% cells stained or Allred Score≥4)
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- HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
- Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance)
- Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations:
- Lobular histology
- Or grade II
- Or grade III and pT < 2cm
- Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration
- Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest
- Signed informed consent and Health insurance coverage
Who cannot join
- Non operable, bilateral, locally advanced, T4 or metastatic breast cancer
- Any lymph node involvement with the exception of pN0i+ or pN1mi
- HER2 Overexpression
- Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
- Any previous systemic or locoregional treatment for the present breast cancer
- Documented inherited predisposition with BRCA1/2 or TP53 mutation
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- Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery
- Previous treatment for the present breast cancer
- Person unable to give informed consent
About this study
Official title: Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments
The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments.
Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- EPClin genomic test
- Keywords
- Genomic test, Chemotherapy decision
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPClin genomic testOther
| Study group | Role | What they receive |
|---|---|---|
| EndoPredict (EP)clin testing | Other | Once the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size. Receives: Other: EPClin genomic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result
Measured: 15 days
Secondary outcomes (2)
Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized "State-Trait-Anxiety Inventory" questionnaires compared with general condition at baseline.
Measured: 1 year
Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionDec 2017
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.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Myriad Genetics, Inc.
- Responsible party
- Sponsor
- Investigators
- Frédérique Penault-Llorca, MD, PhD, Study chair, Centre Jean Perrin, Clermont Ferrand, FranceSuzette Delaloge, MD, Principal investigator, Gustave Roussy, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773004
- Sponsor's protocol ID
- UC-0140/1505 - ADENDOM
- Other IDs
- 2015-A00528-41, PACS14, ADENDOM, UCBG 2-14
- Acronym
- ADENDOM
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2016
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments
- ClinicalTrials.gov ID
- NCT02773004
- Acronym / sponsor ID
- ADENDOM / UC-0140/1505 - ADENDOM
- Conditions
- Breast Cancer
- Keywords
- Genomic test, Chemotherapy decision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Myriad Genetics, Inc.
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- 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 trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments.
Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoPredict (EP)clin testing | Other | Other: EPClin genomic testOnce the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years,
- Performance status 0 or 1,
- Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer
- Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery
- Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation
Key exclusion criteria (9 listed)
- Non operable, bilateral, locally advanced, T4 or metastatic breast cancer
- Any lymph node involvement with the exception of pN0i+ or pN1mi
- HER2 Overexpression
- Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
- Any previous systemic or locoregional treatment for the present breast cancer
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 |
|---|---|---|
| EPClin genomic test | Other | EndoPredict (EP)clin testing |
Primary outcome
The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result
Time frame: 15 days
2 secondary outcomes
Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized "State-Trait-Anxiety Inventory" questionnaires compared with general condition at baseline.
Time frame: 1 year
Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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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.
Frédérique Penault-Llorca, MD, PhD study chair
Centre Jean Perrin, Clermont Ferrand, France
Suzette Delaloge, MD principal investigator
Gustave Roussy, Villejuif, France
Questions about this trial
What is this clinical trial studying?
A study testing EPClin genomic test in people with Breast Cancer, run by UNICANCER.
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 15 inclusion and 9 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: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result (time frame: 15 days). 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 1 Sep 2023.