This phase II trial studies the effect of sacituzumab govitecan in treating patients with
HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab
govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called
govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific
molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan
to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend
the time until the cancer gets worse.
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.
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-).
I. To bank specimens for future correlative studies.
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
After completion of study registration, patients are followed up every 3 months for 1 year
and then every 6 months for 1 year.
Invasive Breast Carcinoma,
Metastatic Malignant Neoplasm in the Brain,
Invasive Breast Cancer,
Anatomic Stage IV Breast Cancer AJCC v8,
Prognostic Stage IV Breast Cancer AJCC v8,
Metastatic HER2 Negative Breast Carcinoma
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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