CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Eribulin +2 moredrug
Likely dose
Eribulin 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/NCT01527487
NCT01527487Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Feb 7, 2012·Updated Nov 4, 2016

In Brief

A Phase 2 clinical trial evaluating Eribulin, Cyclophosphamide, and 1 other intervention for HER2 Negative Breast Cancer. Completed, enrolled 76 participants across 15 sites.

Detailed Summary

The investigators propose a randomized phase II study evaluating the pCR and toxicity profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) as neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2 Negative Breast Cancer
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2014
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.4 years ago

Interventions

Eribulindrug

1.4 mg/m2 IV (Days 1 \& 8), given short (≤15 minute) IV infusion, per institutional standard

Cyclophosphamidedrug

Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.

Docetaxeldrug

Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.