NCT04434040 · Dana-Farber Cancer Institute
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Atezolizumab
Atezolizumab is a type of antibody and is administered intravenously.
DRUG
Sacituzumab govitecan
Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously
Primary outcome measures
Rate of undetectable circulating tumor cfDNA- 6 Cycles
Time frame: 18 Weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the Principal Investigator to establish eligibility
- ER and PR negative in primary tumor pre-treatment defined as \< 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
- Patients must have received neoadjuvant chemotherapy prior to brea
Where
- San Francisco, California
- Chicago, Illinois
- New Lenox, Illinois
- Orland Park, Illinois
- Boston, Massachusetts
- Philadelphia, Pennsylvania
- Nashville, Tennessee
Collaborators
Genentech, Inc., Stand Up To Cancer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations