NCT02581839

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.

Detailed description

Primary Objectives: To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate. Secondary Objective(s): 1\. Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population. 2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate. 3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months). 4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population. 5 Overall survival in this patient population. Design: This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.

Conditions

• Metastatic Breast Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
DEVICE	MRI	An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
DRUG	Pre-Medication: Zofran	Zofran at 8mg orally. Given at the discretion of the treating physician
DRUG	Pre-Medication: Decadron	decadron at 8mg orally. Given at the discretion of the treating physician

Timeline

• Start date: 2015-11-17
• Primary completion: 2018-07-02
• Completion: 2020-07-02
• First posted: 2015-10-21
• Last updated: 2020-07-30
• Results posted: 2020-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study