NCT00097721

A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	E7389	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.

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2004-11-30
• Last updated: 2013-04-22
• Results posted: 2013-03-15

Locations

16 sites across 1 country: United States