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).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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