Study of E7389 for Advanced or Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Eribulin Mesylate

• Registration Number: NCT00965523
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.

Detailed Description

Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Results First Submitted: 2011-12-22
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-14
• Last Update Submitted: 2013-07-14
• Results First Posted: 2013-08-15
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eribulin Mesylate	Eribulin Mesylate	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events.	Every week during treatment and up to 30 days after last dose of study treatment

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)	Every 6 weeks	Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter \[LD\] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.