NCT04647916

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

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Metastatic HER2 Negative Breast Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab Govitecan	Given IV

Timeline

• Start date: 2021-06-08
• Primary completion: 2027-12-31
• Completion: 2028-12-01
• First posted: 2020-12-01
• Last updated: 2025-04-24

Locations

296 sites across 1 country: United States

Regulatory

• FDA-regulated drug study