A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy.

The secondary objectives are to evaluate:

• The safety and tolerability of E7389 monotherapy in this patient population;

• The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival;

• Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS);

• Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT00097721
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Completion date: November 2006