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)

Completed

• Conditions: Breast Cancer
• Interventions: Other: prospective study

• Registration Number: NCT02536625
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Study Start: 2015-10
• Primary Completion: 2019-04
• Study Completion: 2019-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Everolimus	prospective study	Immunomonitoring

Primary Outcome Measures

Name	Time	Method
Measure of the level of Granzyme B (GzmB)	Timepoint at 3 months

Secondary Outcome Measures

Name	Time	Method
mTOR activation status	Timepoint at 3 months and at 9 months	rpS6 phosphorylation rate by western blot
Objective Response Rate	12 months	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
Progression-Free Survival (PFS)	12 months	Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.
Overall Survival (OS)	12 months	Defined as the duration of time from start of treatment to time of death.
Intercurrent diseases reporting	12 months	Number of patients with adverse events (including infectious events) related to everolimus
Circulating NK functions	Timepoint at 3 months and at 9 months	Characterization of circulating NK functions by flow cytometry

Trial Locations

Locations (2)

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France