Objectives
PRIMARY OBJECTIVE:
I. To evaluate the intracranial objective response rate (ORR) (complete response [CR] or partial response [PR] by Response Assessment in Neuro-Oncology Brain Metastases [RANO-BM]) with sacituzumab govitecan (IMMU-132) in patients with HER2-negative metastatic breast cancer with brain involvement.
SECONDARY OBJECTIVES:
I. To evaluate bi-compartmental progression-free survival in this population. II. To evaluate overall survival in this population. III. To assess safety and tolerability of sacituzumab govitecan (IMMU-132) treatment in this population.
IV. To evaluate ORR by hormone-receptor (HR) subgroup (HR+, HR-).
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE:
Patients receive sacituzumab govitecan intravenously (IV) over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study registration, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.