Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)
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.
• 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.
• Eligible for Stereotactic radiosurgery (SRS) to brain metastases or to the post-operative bed.
• Measurable brain disease per RANO-BM criteria1 that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities.
• Maximum diameter of the largest intact brain metastases ≤ 4 cm.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Symptomatic patients having undergone surgery or on stable doses of steroids ≤ 8 mg/day dexamethasone will be enrolled.
• Prior treatment with taxane based chemotherapy with anthracyclines.
• Individuals with prior SRS/fractioned stereotactic radiotherapy (FSRT) treatment will be allowed if active measurable disease has not previously been treated with radiation therapy.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the administration of each dose of study agent.
• Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.