Testing Sacituzumab Govitecan Therapy in Patients with HER2-Negative Breast Cancer and Brain Metastases

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT04647916
Trial Phases:	Phase II	Protocol IDs:	S2007 (primary) S2007 NCI-2020-07706
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	SWOG
NCI Full Details:	http://clinicaltrials.gov/show/NCT04647916

Summary

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.

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.

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