Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Chest Wall Disease
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

There will be a companion translational study operating concurrently with the study described above. In this study, biomarker research to be performed on tumor biopsies and peripheral blood samples will be performed to explore the immunologic and genomic mechanism of action underlying treatment with...

There will be a companion translational study operating concurrently with the study described above. In this study, biomarker research to be performed on tumor biopsies and peripheral blood samples will be performed to explore the immunologic and genomic mechanism of action underlying treatment with pembrolizumab and carboplatin versus carboplatin alone. This protocol includes tissue and blood correlative exploratory endpoints including changes in tumor PD-L1 (programmed death ligand 1) gene expression, tumor and peripheral blood immune composition and cytokine expression, plasma tumor DNA, circulating tumor cells, and tumor myelocytomatosis (MYC) oncogene expression using tumor biopsy and peripheral blood testing before and after treatment; correlations with these markers and disease control rate will be assessed.

Tracking Information

NCT #
NCT03095352
Collaborators
  • Mayo Clinic
  • Johns Hopkins University
  • Translational Breast Cancer Research Consortium
  • Massachusetts General Hospital
  • Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Hope Rugo University of California, San Francisco Principal Investigator: Neelima Vidula Massachusetts General Hospital