Breast CancerEVERIMMUNNCT02854618
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
A study testing additional blood sample in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- additional blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2015to May 2022
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients eligible for a treatment by everolimus in association with the exemestane
- Performance status of 0,1 or 2 according to the WHO
- Patients affected of a breast cancer advanced and\or metastatic HER2 negative expressing the hormonal receptor RH +
- menopausal Patients
Who cannot join
- Psychiatric disease compromising the understanding of the information or the realization of the study
- Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
- Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
- Not menopausal women
- Unaffiliated people to the Social Security
- People being for the period of exclusion from another study
Show all 9Show fewer
- Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
- Symptomatic visceral achievement
- Legal incapacity or limited legal capacity
Trial locations and contacts
1 site in 1 country.
Elsa CURTIT contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire
Besançon, 25030
Elise ROBERT, e1robert@chu-besancon.fr
About this study
Official title: Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus
- Conditions
- Breast Cancer
- Being tested
- additional blood sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Everolimus treatment | Experimental | Not described Receives: Other: additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of the spontaneous anti-telomerase response
evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)
Measured: 12 months
Secondary outcomes (8)
T lymphocytes level
Measured: 12 months
everolimus level in serum patients
Measured: 12 months
angiopoietin 2 level
Measured: 12 months
CD138 level
Measured: 12 months
ps6K expression
Measured: 12 months
Merlin expression
Measured: 12 months
neuropilin 2 expression
Measured: 12 months
quality of life
EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start26 Nov 2015
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
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 Centre Hospitalier Universitaire de BesanconThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854618
- Sponsor's protocol ID
- P/2012/159
- Acronym
- EVERIMMUN
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization
- ClinicalTrials.gov ID
- NCT02854618
- Acronym / sponsor ID
- EVERIMMUN / P/2012/159
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Nov 2015 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 3 Aug 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.
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus treatment | Experimental | Other: additional blood sample |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients eligible for a treatment by everolimus in association with the exemestane
- Performance status of 0,1 or 2 according to the WHO
- Patients affected of a breast cancer advanced and\or metastatic HER2 negative expressing the hormonal receptor RH +
- menopausal Patients
Key exclusion criteria (9 listed)
- Psychiatric disease compromising the understanding of the information or the realization of the study
- Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
- Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
- Not menopausal women
- Unaffiliated people to the Social Security
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 |
|---|---|---|
| additional blood sample | Other | Everolimus treatment |
Primary outcome
level of the spontaneous anti-telomerase response
Time frame: 12 months
evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)
8 secondary outcomes
T lymphocytes level
Time frame: 12 months
everolimus level in serum patients
Time frame: 12 months
angiopoietin 2 level
Time frame: 12 months
CD138 level
Time frame: 12 months
ps6K expression
Time frame: 12 months
Merlin expression
Time frame: 12 months
neuropilin 2 expression
Time frame: 12 months
quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- 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.
Elsa CURTIT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood sample in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsa CURTIT (elsa.curtit@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of the spontaneous anti-telomerase response (time frame: 12 months). 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 Feb 2021.