CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 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/NCT01269346
NCT01269346Phase 2Completed
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A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer

Eisai Inc.·interventional·Posted Jan 4, 2011·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating Eribulin Mesylate for Breast Cancer. Completed, enrolled 52 participants across 26 sites.

Detailed Summary

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 4, 2011
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.5 years ago

Interventions

Eribulin Mesylatedrug

Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.