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NCT02581839 · ClinicalTrials.gov registry record · Phase 2
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
A Phase 2 study of Metastatic Breast Cancer and Brain Metastases, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 2
- Study locations
NCT02581839: Completed Phase 2 study of Metastatic Breast Cancer and Brain Metastases, sponsored by Case Comprehensive Cancer Center.
NCT02581839 is a Phase 2 study of Metastatic Breast Cancer and Brain Metastases that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 9 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581839, a Phase 2 study of Metastatic Breast Cancer and Brain Metastases, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Conditions Studied
Interventions
- DEVICE MRI
- DRUG Eribulin Mesylate
- DRUG Pre-Medication: Zofran
- DRUG Pre-Medication: Decadron
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-11-17 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 2 |
What the finished NCT02581839 record still lists
NCT02581839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which MRI is the first listed.
NCT02581839 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02581839 about?
NCT02581839 is a clinical study titled "Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate". 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 u...
What is the current status of trial NCT02581839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2015-11-17. Estimated completion is 2020-07-02.
What conditions does trial NCT02581839 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Brain Metastases.
What interventions are being tested in trial NCT02581839?
The interventions under investigation include: MRI (DEVICE), Eribulin Mesylate (DRUG), Pre-Medication: Zofran (DRUG), Pre-Medication: Decadron (DRUG).
Who is sponsoring clinical trial NCT02581839?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581839 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02581839's enrollment target sits among peer trials
9 136th of 139 higher than 2 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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