Actively Recruiting
Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
Led by University of Louisville · Updated on 2025-02-20
15
Participants Needed
1
Research Sites
512 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
J
James Graham Brown Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer
CONDITIONS
Official Title
Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older at time of consent
- Histologically confirmed breast cancer diagnosis
- Unresectable or metastatic stage IV breast cancer
- Measurable disease with lesions at least 10 mm in longest diameter or lymph nodes at least 15 mm
- Candidate for palliative stereotactic body radiation therapy (SBRT)
- Received two prior lines of therapy, including taxane for triple negative or CDK 4/6 inhibitor for ER+ patients as applicable
- Adequate organ function within 14 days before enrollment
- ECOG performance status of 0, 1, or 2
- Negative pregnancy test for females of childbearing potential within 72 hours before enrollment
You will not qualify if you...
- More than 4 clinically active brain metastases
- Any other clinically significant disorder or condition posing safety risks or interfering with study
- Active autoimmune disease that could worsen with pembrolizumab
- Clinically significant immunosuppression or immunodeficiency
- Receiving systemic immunosuppressive therapy above specified limits
- Known sensitivity to study treatment components
- Known HIV infection
- Acute or chronic hepatitis B or C infection
- Prior allogeneic stem cell transplant within last 5 years
- History of active tuberculosis
- History or current pneumonitis requiring steroids
- Not indicated for palliative SBRT
- Prior tumor vaccine therapy unless in adjuvant setting
- Currently in another investigational study or less than 28 days since prior study
- Expected need for other cancer therapies except allowed palliative radiation and supportive treatments
- Pregnant, breastfeeding, or planning pregnancy during study and 4 months after last dose
- Unwillingness to use effective contraception during study and 4 months after last dose
- Unlikely to complete all study visits or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
E
Elizabeth Riley, MD
CONTACT
K
Kathleen Coons
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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