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 Type
OBSERVATIONAL
Enrollment
62
Centre Leon Berard
Lyon, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Measure of the level of Granzyme B (GzmB)
Time frame: Timepoint at 3 months
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
Time frame: 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.
Time frame: 12 months
Overall Survival (OS)
Defined as the duration of time from start of treatment to time of death.
Time frame: 12 months
Intercurrent diseases reporting
Number of patients with adverse events (including infectious events) related to everolimus
Time frame: 12 months
Circulating NK functions
Characterization of circulating NK functions by flow cytometry
Time frame: Timepoint at 3 months and at 9 months
mTOR activation status
rpS6 phosphorylation rate by western blot
Time frame: Timepoint at 3 months and at 9 months
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