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
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 years. It is expected that about 40 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied. The U.S. Food and Drug Administration (FDA) has not approved atezolizumab (Tecentriq) for residual triple negative breast cancer but it has been approved for advanced triple negative breast cancer and other cancers. Atezolizumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls your body's natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help your immune system identify and catch tumor cells. The U.S. Food and Drug Administration (FDA) has not approved sacituzumab govitecan (Trodelvy) for your specific disease, but it has been approved for patients with metastatic triple-negative breast cancer who have been treated with 2 or more prior treatment regimens for their cancer. Sacituzumab govitecan is composed of a chemotherapy drug, called Irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors.
Study Type
INTERVENTIONAL
Allocation
Atezolizumab is a type of antibody and is administered intravenously.
Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously
University of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
WITHDRAWNUniversity of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
Rate of undetectable circulating tumor cfDNA- 6 Cycles
Clearance of tumor cfDNA after 18 weeks, it will be tested using a one-sided one-sample binomial exact test (alpha 5%) against a null hypothesis value of 7% false negatives.
Time frame: 18 Weeks
Rate of undetectable circulating tumor cfDNA - 1 Cycle
Proportion of patients with undetectable circulating tumor cfDNA after 1 cycle of combination therapy
Time frame: 3 weeks
Rate of undetectable circulating tumor cfDNA - 3 Cycles
Proportion of patients with undetectable circulating tumor cfDNA after 3 cycles of combination therapy
Time frame: 9 weeks
Number of Participants With Treatment-Related Adverse Events
Type, incidence and severity of adverse events (AEs) as graded by NCI CTCAE v5 criteria by 12 and 24 weeks.
Time frame: 18 Weeks
Invasive disease-free survival (iDFS) Rate
Estimated disease-free survival (iDFS) Rate with 90% CI
Time frame: 3 years
Distant metastasis free survival (DMFS) Rate
Estimated metastasis free survival (DMFS) rate with 90% CI
Time frame: 3 years
Overall survival (OS) Rate
Estimate overall survival rate with 90% CI
Time frame: 3 years
3-year recurrence rate
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NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University of Chicago Medical Center for Advanced Care Orland Park
Orland Park, Illinois, United States
WITHDRAWNDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGVanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGTime frame: 3 Years