CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
eribulin mesylate +1 moredrug
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/NCT01439282
NCT01439282Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

Eisai Inc.·interventional·Posted Sep 23, 2011·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating eribulin mesylate and capecitabine for Estrogen Receptor Positive Tumor and Breast Cancer. Completed, enrolled 77 participants across 23 sites.

Detailed Summary

This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Positive Tumor, Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2011
Enrollment StartAug 1, 2011
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

eribulin mesylatedrug

Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles

capecitabinedrug

Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles