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NCT Number: NCT02536625

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)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Leon Berard, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective study

Other

Primary outcomes

  1. Measure of the level of Granzyme B (GzmB)

    Time frame: Timepoint at 3 months

Secondary outcomes

  1. Objective Response Rate

    Time frame: 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

  2. Progression-Free Survival (PFS)

    Time frame: 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.

  3. Overall Survival (OS)

    Time frame: 12 months

    Defined as the duration of time from start of treatment to time of death.

  4. Intercurrent diseases reporting

    Time frame: 12 months

    Number of patients with adverse events (including infectious events) related to everolimus

  5. Circulating NK functions

    Time frame: Timepoint at 3 months and at 9 months

    Characterization of circulating NK functions by flow cytometry

  6. mTOR activation status

    Time frame: Timepoint at 3 months and at 9 months

    rpS6 phosphorylation rate by western blot

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Ligue contre le cancer, France
  • The Biostatistics and Therapy Evaluation Unit

Registry information

Official study title

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)

Acronym: RAPANK

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2015
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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