At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
Eribulin +1 moredrug
Likely dose
Eribulin 1.4 mgfrom 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.
Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Eribulin and Trastuzumab for Metastatic Breast Cancer. Completed, enrolled 127 participants across 18 sites.
Detailed Summary
The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsEisai Inc.
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartSep 2011
Primary CompletionApr 2017
TodayJul 2026
First PostedJul 26, 2011
Enrollment StartSep 23, 2011
Primary CompletionApr 3, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.9 years ago
Interventions
Eribulindrug
1.4 mg/m\^2 IV Days 1 and 8, every 21 days for six cycles
Trastuzumabdrug
6 mg/kg IV Day 1 every 21 days