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)

NCT02536625 | Completed

• 1 other identifier: RAPANK
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

everolimus; NK; metastatic

Outcome Measures

Primary Outcomes (1)

• Measure of the level of Granzyme B (GzmB)

  Timepoint at 3 months

Secondary Outcomes (6)

• Objective Response Rate

  12 months

• Progression-Free Survival (PFS)

  12 months

• Overall Survival (OS)

  12 months

• Intercurrent diseases reporting

  12 months

• Circulating NK functions

  Timepoint at 3 months and at 9 months

Study Arms (1)

Everolimus

Immunomonitoring

Other: prospective study

Interventions

prospective study OTHER

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• The Biostatistics and Therapy Evaluation Unit: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (2)

Centre Leon Berard

Lyon, 69008, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• TREDAN Olivier, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: September 1, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

FR (2)