Actively Recruiting
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
Led by Dana-Farber Cancer Institute · Updated on 2026-04-29
110
Participants Needed
15
Research Sites
453 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
CONDITIONS
Official Title
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed invasive breast cancer with locally advanced or metastatic disease.
- Breast cancer must be triple-negative: estrogen and progesterone receptor expression both 5% or less and HER2-negative.
- PD-L1-negative metastatic breast cancer defined by standard testing.
- No prior treatment for metastatic breast cancer.
- Must have measurable or evaluable disease; patients with bone-only disease allowed.
- Agree to research biopsies if tumor is safely accessible, including a repeat biopsy 3-6 weeks after starting treatment.
- No prior irinotecan or topoisomerase I-containing antibody drug conjugates.
- Prior chemotherapy for metastatic breast cancer must have ended at least 28 days before study treatment.
- Prior biologic therapy must have ended at least 28 days before study treatment.
- Prior radiation therapy must be completed at least 7 days before study treatment.
- Previously treated brain metastases allowed if stable and off steroids for at least 7 days.
- Age 18 years or older.
- ECOG performance status 0-1.
- Normal organ and marrow function as defined by specific laboratory criteria.
- Negative pregnancy test for females of childbearing potential within 2 weeks prior to treatment.
- Women of childbearing potential and sexually active males must agree to use effective contraception.
- Participants on bisphosphonates or RANK ligand inhibitors may continue or start these therapies.
- Must be able to understand and comply with study procedures and provide informed consent.
You will not qualify if you...
- Received systemic anti-cancer therapy within 4 weeks before study treatment, except bisphosphonates and RANK ligand inhibitors.
- Prior treatment with anti-PD-1, PD-L1, PD-L2 agents, or sacituzumab govitecan.
- Prior irinotecan or topoisomerase I-containing antibody drug conjugates at any disease stage.
- Known allergy or hypersensitivity to pembrolizumab or sacituzumab govitecan.
- Known UGT1A1 *28 homozygosity.
- Untreated, symptomatic, or uncontrolled brain metastases.
- Major surgery within 2 weeks before study treatment.
- Uncontrolled or significant ongoing illness or infection.
- Requires chronic systemic steroid therapy or immunosuppressive medication.
- History of autoimmune disease needing systemic steroids or immunosuppressants.
- History or current pneumonitis requiring steroids.
- History of other malignancy within 3 years except certain low-risk cancers.
- Known HIV, active Hepatitis B or C infection.
- Received live vaccine within 28 days before study treatment.
- Any condition or laboratory abnormality that may interfere with study participation.
- Currently breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Stamford Hospital
Stamford, Connecticut, United States, 06904
Actively Recruiting
2
Miami Cancer Institute at Baptist Health (Kendall)
Miami, Florida, United States, 33176
Actively Recruiting
3
Miami Cancer Institute at Baptist Health
Plantation, Florida, United States, 33324
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Eastern Maine Medical Center
Brewer, Maine, United States, 04412
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
DFCI @ Foxborough
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
8
DFCI @ Milford Regional Hospital
Milford, Massachusetts, United States, 01757
Actively Recruiting
9
DF/BWCC in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
Actively Recruiting
10
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Ohio State University Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
13
University of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
15
Sarah Cannon Research Institute
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
Research Team
A
Ana C Garrido-Castro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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