Breast CancerRAPANKNCT02536625
Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
An observational study of Breast Cancer, run by Centre Leon Berard at 2 sites in France.
Trial summary
NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic 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?
- prospective study
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2015to Dec 2019
- Phase
- Observational
- 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
Study population: Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative) eligible for a treatment with everolimus in this application
Who may be able to join
- Women > 18 years old
- Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human Epidermal Growth Factor Receptor-2)
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤2
- Eligible to an hormonotherapy treatment combined to an mTOR (mammalian Target Of Rapamycin) inhibitor (i.e. SPC (Summary of Product Characteristics) modalities)
- Measurable disease according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)
- Not receiving the non-authorized concomitant treatments
- Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- Patients must be covered by a medical insurance
Who cannot join
- BMI>30
- All dysimmune disease, history of transplantation or immunosuppressive therapy or corticotherapy
- All chronic inflammatory diseases
- Last chemotherapy < 6 months
- Corticotherapy <1 year and more than 1 month
- Restrictive diet ≤3 months before inclusion
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Leon Berard
Lyon, 69008
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.
- Conditions
- Breast Cancer
- Being tested
- prospective study
- Keywords
- everolimus, NK, metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective studyOther
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Immunomonitoring Receives: Other: prospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the level of Granzyme B (GzmB)
Measured: Timepoint at 3 months
Secondary outcomes (6)
Objective Response Rate
The objective response rate (ORR) will be defined as the proportion of patients (described on the efficacy-evaluable population) who achieve complete response (CR) or partial response (PR). ORR is based on tumor assessments (measurements according to RECIST 1.1
Measured: 12 months
Progression-Free Survival (PFS)
Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.
Measured: 12 months
Overall Survival (OS)
Defined as the duration of time from start of treatment to time of death.
Measured: 12 months
Intercurrent diseases reporting
Number of patients with adverse events (including infectious events) related to everolimus
Measured: 12 months
Circulating NK functions
Characterization of circulating NK functions by flow cytometry
Measured: Timepoint at 3 months and at 9 months
mTOR activation status
rpS6 phosphorylation rate by western blot
Measured: Timepoint at 3 months and at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2019
- Study completionDec 2019
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 Leon BerardThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit, Institut National de la Santé Et de la Recherche Médicale, France, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- TREDAN Olivier, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536625
- Sponsor's protocol ID
- RAPANK
- Acronym
- RAPANK
- Status last verified
- Feb 2021
- First submitted
- 14 Aug 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
- ClinicalTrials.gov ID
- NCT02536625
- Acronym / sponsor ID
- RAPANK / RAPANK
- Conditions
- Breast Cancer
- Keywords
- everolimus, NK, metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit, Institut National de la Santé Et de la Recherche Médicale, France, Ligue contre le cancer, France
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Sep 2015 (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.
NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | – | Other: prospective studyImmunomonitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative) eligible for a treatment with everolimus in this application
Key inclusion criteria (8 listed)
- Women > 18 years old
- Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human Epidermal Growth Factor Receptor-2)
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤2
- Eligible to an hormonotherapy treatment combined to an mTOR (mammalian Target Of Rapamycin) inhibitor (i.e. SPC (Summary of Product Characteristics) modalities)
- Measurable disease according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)
Key exclusion criteria (6 listed)
- BMI>30
- All dysimmune disease, history of transplantation or immunosuppressive therapy or corticotherapy
- All chronic inflammatory diseases
- Last chemotherapy < 6 months
- Corticotherapy <1 year and more than 1 month
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 |
|---|---|---|
| prospective study | Other | Everolimus |
Primary outcome
Measure of the level of Granzyme B (GzmB)
Time frame: Timepoint at 3 months
6 secondary outcomes
Objective Response Rate
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Intercurrent diseases reporting
Time frame: 12 months
Circulating NK functions
Time frame: Timepoint at 3 months and at 9 months
mTOR activation status
Time frame: Timepoint at 3 months and at 9 months
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 4 Feb 2021.
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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.
TREDAN Olivier, MD principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Leon Berard at 2 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 8 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: finished, as of the sponsor's last update on 4 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 2 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 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?
Measure of the level of Granzyme B (GzmB) (time frame: Timepoint at 3 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 4 Feb 2021.