NCT00965523

Study of E7389 for Advanced or Metastatic Breast Cancer

Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Eribulin mesylate 1.4 mg/m\^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-08-25
• Last updated: 2013-08-15
• Results posted: 2013-08-15

Locations

5 sites across 1 country: Japan