CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Eribulin Mesylatedrug
Likely dose
Eribulin Mesylate 1.4 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02481050
NCT02481050Phase 2Completed

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

Eisai Inc.·interventional·Posted Jun 25, 2015·Updated Nov 15, 2018

In Brief

A Phase 2 clinical trial evaluating Eribulin Mesylate for Breast Cancer. Completed, enrolled 58 participants across 12 sites.

Detailed Summary

This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 25, 2015
Enrollment StartJun 16, 2015
Primary CompletionDec 31, 2016
Study CompletionSep 5, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.0 years ago

Interventions

Eribulin Mesylatedrug

Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes biweekly on Day 1 and Day 15 of each 28-day cycle.