H. Lee Moffitt Cancer Center and Research Institute
This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
Inclusion Criteria: * Provision of signed and dated Informed Consent Form (ICF). * Stated willingness to comply with all study procedures and availability for the duration of the study. * Age ≥ 18. * Triple negative breast cancer; to fulfill the requirement of triple negative disease, a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]). * Breast cancer as documented by extracranial tumor biopsy with brain metastases documented from MRI brain imaging or intracranial surgical pathology. * Eligi…
Stereotactic Radiation to intact brain metastases or post-operative cavity.
One week +/- 4 days following receipt of SRS, zimberelimab 360 mg IV will be administered. This will be followed by zimberelimab 360 mg IV every 3 weeks.
SG will be administered on days 1 and 8 (10 mg/kg) of 21 day treatment cycles. This will be one week +/- 4 days following receipt of SRS for the first dose.
Arctuva estimate
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