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Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

NCT02581839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-07-30

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Paula Silverman, MD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-17
Primary Completion
2018-07-02
Completion
2020-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581839 on ClinicalTrials.gov