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)
NCT ID: NCT02536625
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62 participants
OBSERVATIONAL
2015-10-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Everolimus
Immunomonitoring
prospective study
Interventions
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prospective study
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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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
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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TREDAN Olivier, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Leon Berard
Lyon, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Other Identifiers
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RAPANK
Identifier Type: -
Identifier Source: org_study_id
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