NCT00388726

E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 762 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	E7389	1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
DRUG	Physician's Choice	Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-05-01
• Completion: 2013-06-01
• First posted: 2006-10-17
• Last updated: 2020-01-07
• Results posted: 2012-01-30

Locations

137 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Hungary, Italy, Poland, Russia, South Africa, Spain, Switzerland