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
This study will enroll subjects who are female aged \> 18 years at the time of informed consent with histologically confirmed diagnosis of breast cancer (unresectable or metastatic stage IV breast cancer). Subjects must have measurable disease and be a candidate for palliative stereotactic body radiation therapy (SBRT). Subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2 and adequate hematologic, hepatic, renal, and coagulation function. Subject must also have received two prior lines of FDA-approved therapy. Triple negative patients must have had prior exposure to taxane therapy either in the neoadjuvant/adjuvant or metastatic setting. ER + positive patients must have had prior cyclin dependent kinase (CDK) 4/6 inhibitor therapy. Her2 overexpressed patients must have had prior therapy with trastuzumab and ado-trastuzumab (TDM-1).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Stereotactic radiation therapy will be administered as clinically indicated.
James Graham Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGPrimary Outcome Measure
Overall Response Rate (complete response \[CR\]+partial response \[PR\] by investigator assessment using modified RECIST v1.1) at week 24
Time frame: 3.0 years
Secondary Outcome Measures-Best Overall Response Rate
Best Overall Response Rate (complete response \[CR\]+partial response \[PR\] by investigator assessment using modified RECIST v1.1)
Time frame: 3.0 years
Secondary Outcome Measures-Progression-free Survival
Progression-free Survival (PFS)
Time frame: 3.0 years
Secondary Outcome Measures-Incidence of treatment-emergent and treatment-related adverse events
Incidence of treatment-emergent and treatment-related adverse events as defined by
Time frame: 3.0 years
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