Spots Global Cancer Trial Database for Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

Study Description

Brief Summary: 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.

Detailed Description: 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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