Finding studies
Finding studies
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Lead
Vanderbilt-Ingram Cancer Center
With
Primary objective: To evaluate the efficacy, as measured by progression free survival (PFS) of carboplatin + atezolizumab (using irRECIST) versus carboplatin alone (using RECIST) in patients with triple negative metastatic breast cancer Secondary objectives: * To determine overall response rate. * To evaluate the efficacy, as measured by clinical benefit rate, of carboplatin + atezolizumab (using irRECIST) versus carboplatin (using RECIST) alone in patients with triple negative metastatic breast cancer. Clinical benefit rate is defined as complete response plus partial response plus stable disease for 6 months. * To determine the duration of response for patients achieving a partial or complete response. * To evaluate the overall survival (OS) of carboplatin + atezolizumab versus carboplatin alone in patients with triple negative metastatic breast cancer. TERTIARY OBJECTIVES: * To perform the following correlative studies from biopsies taken at baseline: 1. Tumor infiltrating lymphocyte frequency and phenotype (TILs) at baseline 2. PD-L1 expression from the baseline pre-treatment tissue and at progression lesion, performed by IHC (SP142 clone) 3. HER2 (IHC, FISH) and ER/PR levels (IHC) from a metastatic site 4. Perform RNA-seq to determine non-synonymous mutation burden in expressed genes and gene expression to assign a triple negative subtype at baseline for correlations with clinic outcome 5. Immune phenotyping (IHC) for markers of T cell subsets and activation (CD4, CD8, FoxP3, CD25, Glut1) and exhaustion (PD1, CTLA4) and test feasibility of flow cytometric analyses to include additional markers * To assess the effect of BRCA mutations on response to the study drugs * To evaluate the effect of steroids on the efficacy of atezolizumab To assess the prognostic effects of TILs on PFS and CBR in patients receiving atezolizumab
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
