A Single Arm Phase 2 Trial of Atezolizumab With Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer (ASPRIA)
Dana-Farber Cancer Institute
Summary
The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
Description
This is an open label single-arm phase II study to evaluate the combination therapy of the antibody drug conjugate, sacituzumab govitecan, and the anti-PD-L1 antibody, atezolizumab, in patients with triple negative breast cancer. The research study procedures include screening for eligibility and study treatment including laboratory evaluations, stool collection and follow up visits. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab Participants will receive study treatment for 18 weeks and will be followed for every 6 months for 3 yea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically confirmed residual invasive breast cancer, in the breast and/or lymph node(s), following neoadjuvant chemotherapy. In the absence of residual invasive disease in the breast, lymph node must contain at least 2mm of invasive disease. * HER2 negative in primary tumor pre-treatment by local pathology assessed according to current ASCO/CAP guidelines: * In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR * Immunohistochemistry (IHC) 0 or IHC 1+. * NOTE: If more than one t…
Interventions
- DrugAtezolizumab
Atezolizumab is a type of antibody and is administered intravenously.
- DrugSacituzumab govitecan
Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously
Locations (7)
- University of California San FranciscoSan Francisco, California
- University of Chicago Medical CenterChicago, Illinois
- University of Chicago Comprehensive Cancer Center at Silver Cross HospitalNew Lenox, Illinois
- University of Chicago Medical Center for Advanced Care Orland ParkOrland Park, Illinois
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Pennsylvania-Abramson Cancer CenterPhiladelphia, Pennsylvania