Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prospective study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Everolimus
- description
- Immunomonitoring
- interventionNames
- Other: prospective study
Primary outcomes (1)
- measure
- Measure of the level of Granzyme B (GzmB)
- timeFrame
- Timepoint at 3 months
Secondary outcomes (6)
- measure
- Objective Response Rate
- timeFrame
- 12 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available