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)

Léon Bérard Center

Status: Completed

Conditions: Breast Cancer

Treatments: Other: prospective study

Study type: Observational

Funder types: Other

Identifiers

NCT02536625

RAPANK

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

62 participants in 1 patient group

Everolimus

Description:

Immunomonitoring

Treatment:

Other: prospective study