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| Name | Class |
|---|---|
| The Biostatistics and Therapy Evaluation Unit | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Ligue contre le cancer, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Immunomonitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prospective study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the level of Granzyme B (GzmB) | Timepoint at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative) eligible for a treatment with everolimus in this application
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| Name | Affiliation | Role |
|---|---|---|
| TREDAN Olivier, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leon Berard | Lyon | 69008 | France | |||
| Centre Hospitalier Lyon Sud |
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Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death. |
| 12 months |
| Overall Survival (OS) | Defined as the duration of time from start of treatment to time of death. | 12 months |
| Intercurrent diseases reporting | Number of patients with adverse events (including infectious events) related to everolimus | 12 months |
| Circulating NK functions | Characterization of circulating NK functions by flow cytometry | Timepoint at 3 months and at 9 months |
| mTOR activation status | rpS6 phosphorylation rate by western blot | Timepoint at 3 months and at 9 months |
| Pierre-BĂ©nite |
| 69495 |
| France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011446 | Prospective Studies |
| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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