Study on Atezolizumab and Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer (ASPRIA)
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04434040
This clinical trial is testing a combination of two drugs, sacituzumab govitecan and atezolizumab, to see if they can help treat remaining cancer in the breast or lymph nodes and detect cancer DNA in the blood for patients with triple negative breast cancer.
Patient Parameters
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Program Overview
The goal of this study is to find out if using two drugs, sacituzumab govitecan and atezolizumab, can effectively treat any remaining cancer in the breast or lymph nodes and detect cancer DNA in the blood for patients with triple negative breast cancer. These drugs are being tested to see if they can help prevent the cancer from coming back.
Description
This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new drug combination to see if it works for treating a specific disease. In this case, the study is looking at sacituzumab govitecan and atezolizumab for patients with triple negative breast cancer. Participants will receive the study treatment for 18 weeks and will be monitored every 6 months for 3 years. About 40 people are expected to take part in this study.
Sacituzumab govitecan is a drug that combines a chemotherapy medicine with an antibody that targets cancer cells. Atezolizumab is a drug that helps the immune system recognize and attack cancer cells by blocking a pathway that usually prevents the immune system from working properly against tumors.
The U.S. Food and Drug Administration (FDA) has approved atezolizumab for advanced triple negative breast cancer and other cancers, but not specifically for residual triple negative breast cancer. Sacituzumab govitecan is approved for patients with metastatic triple-negative breast cancer who have already tried other treatments.
Participants will go through screening to see if they are eligible, and the study will include lab tests, stool collection, and follow-up visits. The study is open label, meaning both the researchers and participants know which treatment is being given.
Eligibility Criteria
Inclusion Criteria
- Have confirmed remaining invasive breast cancer in the breast or lymph nodes after chemotherapy.
- The cancer must be HER2 negative and have less than 10% of cells showing hormone receptors.
- Must have received chemotherapy before breast surgery.
- Be within 4 months of finishing all local treatments like surgery or radiation.
- Have evidence of cancer DNA in the blood after all treatments.
- Can be taking bone-strengthening medications.
- May have had prior immune therapy before surgery.
- Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
- Be 18 years or older.
- Have adequate blood and organ function based on specific lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
- Must understand and agree to sign a consent form.
Exclusion Criteria
- Have had previous treatment with sacituzumab govitecan or similar drugs.
- Have received chemotherapy after surgery.
- Have allergies to atezolizumab or sacituzumab govitecan.
- Have signs of cancer spread to other parts of the body.
- Have only non-invasive cancer remaining.
- Be enrolled in another investigational therapy trial.
- Have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
- Have had major surgery within 4 weeks before starting the study.
- Have taken antibiotics for an active infection within 2 weeks before starting the study.
- Have serious ongoing illnesses or infections.
- Have significant heart or lung diseases.
- Have active autoimmune diseases, except for certain controlled conditions.
- Have gastrointestinal issues that affect drug absorption.
- Have certain heart conditions or abnormal heart rhythms.
- Be positive for HIV, Hepatitis B, or Hepatitis C.
- Have a history of other cancers unless disease-free for 5 years.
- Be taking certain medications that affect the study drugs.
- Have received a live vaccine recently.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Francisco | 94115 | San Francisco | California |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | 60451 | New Lenox | Illinois |
| University of Chicago Medical Center for Advanced Care Orland Park | 60462 | Orland Park | Illinois |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| University of Pennsylvania-Abramson Cancer Center | 19104 | Philadelphia | Pennsylvania |
| Vanderbilt-Ingram Cancer Center | 37232 | Nashville | Tennessee |
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