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Brief Title: A Study of E7389 in Advanced/Metastatic Breast Cancer Patients
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
Study ID: NCT00097721
Brief 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
, Jonesboro, Arkansas, United States
, Deer Park, California, United States
, La Verne, California, United States
, Pasadena, California, United States
, Pomona, California, United States
, Brooksville, Florida, United States
, New Port Richey, Florida, United States
, Plantation, Florida, United States
, New Orleans, Louisiana, United States
, Southaven, Mississippi, United States
, Missoula, Montana, United States
, Syracuse, New York, United States
, Middletown, Ohio, United States
, Memphis, Tennessee, United States
, Amarillo, Texas, United States
, Richardson, Texas, United States
Name: Dale Shuster, Ph.D.
Affiliation: Eisai Inc.
Role: STUDY_DIRECTOR