Carboplatin With or Without Atezolizumab in Treating Patients With Stage IV Triple Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 185
Summary
- Conditions
- HER2 Negative
- Invasive Breast Cancer
- Stage IV Breast Cancer
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 ev...
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: Tumor infiltrating lymphocyte frequency and phenotype (TILs) at baseline PD-L1 expression from the baseline pre-treatment tissue and at progression lesion, performed by IHC (SP142 clone) HER2 (IHC, FISH) and ER/PR levels (IHC) from a metastatic site 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 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
Tracking Information
- NCT #
- NCT03206203
- Collaborators
- National Cancer Institute (NCI)
- Genentech, Inc.
- Investigators
- Not Provided
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