Actively Recruiting
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
Led by Dana-Farber Cancer Institute · Updated on 2026-05-04
40
Participants Needed
7
Research Sites
391 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial 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. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
CONDITIONS
Official Title
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed residual invasive breast cancer in the breast and/or lymph nodes after neoadjuvant chemotherapy
- HER2 negative status in primary tumor by local pathology following ASCO/CAP guidelines
- Estrogen receptor (ER) and progesterone receptor (PR) negative in primary tumor defined as less than 10% expression
- Received neoadjuvant chemotherapy before breast surgery
- Within 4 months of completing all local treatments including surgery and radiation
- Evidence of circulating tumor DNA in blood sample after completing neoadjuvant therapy
- Concurrent use of bone modifying agents allowed
- Prior immune checkpoint inhibitor treatment in neoadjuvant setting allowed
- ECOG Performance Status 0 or 1
- Men and women aged 18 years or older
- Adequate blood counts and organ function as specified
- Negative pregnancy test within 7 days before starting therapy for women of childbearing potential
- Agreement to use effective contraception during treatment and for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with sacituzumab govitecan, irinotecan, or topoisomerase I antibody-drug conjugates for early stage disease
- Receipt of adjuvant chemotherapy outside preoperative setting
- Known hypersensitivity to atezolizumab or sacituzumab govitecan or their ingredients
- Evidence of metastatic disease by clinical or radiographic evaluation
- Residual DCIS or LCIS alone without invasive cancer or specific residual disease statuses
- Participation in another investigational therapy trial concurrently
- Unresolved treatment-related toxicities above Grade 1 except alopecia or peripheral neuropathy
- Major surgery within 4 weeks before study treatment or planned during study
- Use of therapeutic oral or IV antibiotics within 2 weeks before study treatment, except prophylactic antibiotics
- Active infections, serious liver disease, uncontrolled diabetes, or certain uncontrolled metabolic conditions
- Significant cardiovascular disease or recent serious cardiac events
- History or evidence of certain lung diseases or active pneumonitis
- Active autoimmune diseases except specific well-controlled conditions
- Gastrointestinal diseases affecting absorption of study drugs
- Congenital long QT syndrome or prolonged QT interval
- Known positive status for HIV, Hepatitis B or C
- History of prior invasive breast cancer
- Prior malignancies except thyroid cancer treated without spread and disease-free for 5 years
- Use of strong UGT1A1 inhibitors or inducers within 4 weeks before study drug
- Receipt of live vaccines within 4 weeks before treatment or anticipated need during study
- Known allergies to study drugs or their components
- Use of systemic immunosuppressive medications within 2 weeks before treatment except certain allowed exceptions
- Pregnant or breastfeeding women are excluded due to unknown drug effects on fetus or infant
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Withdrawn
3
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States, 60451
Withdrawn
4
University of Chicago Medical Center for Advanced Care Orland Park
Orland Park, Illinois, United States, 60462
Withdrawn
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
University of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
E
Elizabeth A Mittendorf, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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