Clinical trial NCT02536625: 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: everolimus
NK
metastatic
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: The Biostatistics and Therapy Evaluation Unit
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Ligue contre le cancer, France
First posted: 2015-09-01
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative) eligible for a treatment with everolimus in this application

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measure of the level of Granzyme B (GzmB)
timeFrame: Timepoint at 3 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 12 months
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Intercurrent diseases reporting
timeFrame: 12 months
measure: Circulating NK functions
timeFrame: Timepoint at 3 months and at 9 months
measure: mTOR activation status
timeFrame: Timepoint at 3 months and at 9 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Centre Leon Berard
name: TREDAN Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References: