CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
E7389drug
Likely dose
E7389 1.4 mg/m² IV bolus on Days 1, 8, 15 of a 28-day cycle (Cohort 1) or Days 1, 8 of a 21-day cycle (Cohort 2)AI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed advanced/metastatic breast carcinoma not amenable to curative therapy
  • ✓Measurable disease per RECIST (≥10 mm by spiral CT or ≥20 mm by standard techniques)
  • ✓Prior treatment with both an anthracycline and a taxane (sequential or combined)
  • ✓Disease progression within 6 months of last chemotherapy dose OR progression during advanced/metastatic chemotherapy
Key exclusion· 15
  • ✕Chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 start
  • ✕Radiation therapy encompassing >10% of marrow
  • ✕Prior Mitomycin C or nitrosoureas
  • ✕Prior high-dose chemotherapy with stem cell rescue within 2 years

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

Search/NCT00097721
NCT00097721Phase 2Completed
CompareCT.gov

A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients With Advanced/Metastatic Breast Cancer Previously Treated With Chemotherapy Including An Anthracycline and A Taxane

Eisai Inc.·interventional·Posted Nov 30, 2004·Updated Apr 22, 2013

In Brief

A Phase 2 clinical trial evaluating E7389 for Breast Neoplasms. Completed, enrolled 104 participants across 16 sites.

Detailed Summary

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2004
Enrollment StartSep 1, 2004
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.6 years ago

Interventions

E7389drug

The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.