Actively Recruiting
A Single Arm Phase 2 Trial of Atezolizumab With Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer (ASPRIA)
Led by Dana-Farber Cancer Institute · Updated on 2026-05-04
40
Participants Needed
7
Research Sites
52 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
Researchers are evaluating a combination of two investigational drugs, sacituzumab govitecan and atezolizumab, as a treatment for patients with triple negative breast cancer who have residual cancer in the breast or lymph nodes and circulating tumor DNA in their blood. This phase II trial aims to determine if these drugs work together to prevent cancer recurrence after prior treatments including chemotherapy and surgery. The study includes patients with HER2-negative, hormone receptor-negative breast cancer who have completed neoadjuvant chemotherapy and locoregional therapy. Participants will receive the combination therapy for 18 weeks, consisting of six cycles of treatment. Atezolizumab is given intravenously on day 1 of each 21-day cycle, while sacituzumab govitecan is given intravenously on days 1 and 8 of each cycle. After completing treatment, participants will be followed every six months for up to three years to monitor their health and cancer status. During the study, participants will undergo screening to confirm eligibility, laboratory tests, stool collection, and regular follow-up visits. Researchers will measure the rate at which circulating tumor DNA becomes undetectable after treatment cycles, as well as track treatment-related side effects and long-term outcomes such as disease-free survival and overall survival over three years. This comprehensive monitoring aims to assess both the immediate and lasting effects of the drug combination.
CONDITIONS
Brief Title
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed residual invasive breast cancer in the breast and/or lymph nodes after neoadjuvant chemotherapy
- HER2 negative status in the primary tumor according to ASCO/CAP guidelines
- Estrogen receptor (ER) and progesterone receptor (PR) negative in the primary tumor (<10% cells expressing receptors)
- Completion of neoadjuvant chemotherapy prior to breast surgery
- Completion of all locoregional therapy (surgery and radiation) within 4 months before enrollment
- Evidence of circulating tumor DNA in blood after all local and systemic therapy
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function as specified
- Agreement to use adequate contraception during treatment and for 6 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior therapy with sacituzumab govitecan, irinotecan, or similar antibody-drug conjugates for early-stage disease
- Receipt of adjuvant chemotherapy outside the preoperative setting
- Known hypersensitivity to atezolizumab or sacituzumab govitecan or their components
- Evidence of metastatic disease
- Residual non-invasive breast cancer without invasive disease
- Concurrent participation in another investigational therapy trial
- Unresolved treatment-related toxicity greater than grade 1 except alopecia and peripheral neuropathy
- Recent major surgery within 4 weeks before treatment
- Use of therapeutic antibiotics within 2 weeks before treatment (except prophylactic use)
- Active infections or serious uncontrolled illnesses
- Certain cardiovascular diseases
- History of specific lung diseases or active pneumonitis
- Active autoimmune diseases except specified controlled conditions
- Gastrointestinal issues affecting absorption of study drugs
- Congenital long QT syndrome or prolonged QT interval
- Positive for HIV, Hepatitis B, or Hepatitis C
- Prior invasive breast cancer history
- Other malignancies within 5 years except treated thyroid cancer
- Recent use of strong UGT1A1 inhibitors or inducers
- Recent live vaccine administration
- Use of systemic immunosuppressive medications within 2 weeks before treatment except specified exceptions
- Pregnant or breastfeeding women
- Known allergy to study drugs or related products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 18 weeks
Participants receive treatment with Atezolizumab and Sacituzumab govitecan administered intravenously in 6 cycles over 18 weeks.
6 treatment cycles with visits on Day 1 and Day 8 of each 21-day cycle
Duration - 3 years
Participants are followed for safety and disease recurrence every 6 months.
Visits every 6 months for up to 3 years
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
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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