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: 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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02536625

Acronym

RAPANK

Enrollment

Registered

2015-09-01

Start date

2015-10-31

Completion date

2019-12-31

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

everolimus, NK, metastatic

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.

Interventions

OTHERprospective study

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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
Circulating NK functions	Timepoint at 3 months and at 9 months	Characterization of circulating NK functions by flow cytometry
mTOR activation status	Timepoint at 3 months and at 9 months	rpS6 phosphorylation rate by western blot
Intercurrent diseases reporting	12 months	Number of patients with adverse events (including infectious events) related to everolimus

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026