CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 298 enrolled
Drug / intervention
E7389drug
Likely dose
E7389 1.4 mg/m² intravenous bolus over 2-5 minutes on days 1 and 8 every 21 daysAI-extracted
Key inclusion· 7
  • ✓Female patients with histologically or cytologically confirmed breast carcinoma
  • ✓Locally advanced or metastatic disease with 2-5 prior chemotherapy regimens, at least one for advanced/metastatic disease
  • ✓Prior treatment must have included anthracycline, taxane, and capecitabine in any combination or order
  • ✓HER2+ patients must have received prior trastuzumab; ER+ patients may have received endocrine therapy
Key exclusion· 4
  • ✕Chemotherapy, radiation, or biologic therapy within 2 weeks; hormonal therapy within 1 week; trastuzumab within 3 weeks before E7389
  • ✕Prior radiation therapy encompassing >30% of bone marrow; irradiated lesions cannot be target lesions unless they have progressed post-irradiation
  • ✕Pre-existing neuropathy >Grade 2
  • ✕Prior participation in an E7389 clinical trial

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

Search/NCT00246090
NCT00246090Phase 2Completed
CompareCT.gov

A Phase II Open Label Single-Arm Study of E7389 in Patients With Locally Advanced or Metastatic Breast Cancer, Previously Treated With Anthracycline, Taxane, and Capecitabine Therapy, Refractory to the Last Prior Therapy for Their Disease

Eisai Inc.·interventional·Posted Oct 31, 2005·Updated Jul 14, 2014

In Brief

A Phase 2 clinical trial evaluating E7389 for Breast Cancer. Completed, enrolled 298 participants across 65 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, United States
CollaboratorsEisai Limited

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2005
Enrollment StartOct 1, 2005
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.7 years ago

Interventions

E7389drug

E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.