Metastatic Breast Cancer Clinical Trial
Official title:
A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4
lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic
breast cancer patients.
The primary objective is to determine the optimal schedule to deliver CYT107 during
chemotherapy based on restoration of CD4 count.
This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.
24 patients will be included in the study.
A key secondary objective is to determine if CYT107 treatment enables to reduce the
incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3)
post-chemotherapy.
Other secondary objectives are to assess the impact of CYT107 treatment on the following
parameters:
- Overall incidence of side effects (any type any grade)
- Progression-free survival (PFS)
- Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
- CD4 lymphopenia over the study period
Exploratory biological markers
A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will:
- selectively stimulate the proliferation and activation of peripheral immune subsets
(analysis of phenotype and activation status of peripheral immune e sub-populations)
- selectively improve the functional response of T cells, DC subsets and NK cells.
- is able to revert tolerogenic immune burden to increase specific anti-tumor response
(measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
- enable to increase TCR diversity (analysis of combinatorial diversity).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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