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) (RAPANK)

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)

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: prospective study

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Leon Berard
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Everolimus; Immunomonitoring	Other: prospective study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of the level of Granzyme B (GzmB)	Timepoint at 3 months

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Ligue contre le cancer, France; The Biostatistics and Therapy Evaluation Unit
• Investigators: Principal Investigator: TREDAN Olivier, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: everolimus; metastatic; NK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RAPANK