A Study of E7389 in Advanced/Metastatic Breast Cancer Patients
The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Confirmed 4 to 8 weeks after first observed ] [ Designated as safety issue: No ]Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
- Duration of Response [ Time Frame: From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease ] [ Designated as safety issue: No ]Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).
- Progression Free Survival [ Time Frame: From start of study drug administration to progressive disease or death ] [ Designated as safety issue: No ]Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.
- Overall Survival [ Time Frame: From start of study drug administration to death ] [ Designated as safety issue: No ]Defined as the time from the start of study drug administration until death from any cause
- Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores [ Time Frame: At Screening, Day 1 of each cycle, and 30 days after last dose of study drug ] [ Designated as safety issue: No ]The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.
|Study Start Date:||September 2004|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097721
|United States, Arkansas|
|Jonesboro, Arkansas, United States|
|United States, California|
|Deer Park, California, United States|
|La Verne, California, United States|
|Pasadena, California, United States|
|Pomona, California, United States|
|United States, Florida|
|Brooksville, Florida, United States|
|New Port Richey, Florida, United States|
|Plantation, Florida, United States|
|United States, Louisiana|
|New Orleans, Louisiana, United States|
|United States, Mississippi|
|Southaven, Mississippi, United States|
|United States, Montana|
|Missoula, Montana, United States|
|United States, New York|
|Syracuse, New York, United States|
|United States, Ohio|
|Middletown, Ohio, United States|
|United States, Tennessee|
|Memphis, Tennessee, United States|
|United States, Texas|
|Amarillo, Texas, United States|
|Richardson, Texas, United States|
|Study Director:||Dale Shuster, Ph.D.||Eisai Inc.|