At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 762 enrolled

Drug / intervention

E7389 +1 moredrug

Likely dose

E7389 1.4 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00388726

NCT00388726Phase 3Completed

Compare CT.gov

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

Eisai Inc.·interventional·Posted Oct 17, 2006·Updated Jan 7, 2020

In Brief

A Phase 3 clinical trial evaluating E7389 and Physician's Choice for Breast Cancer. Completed, enrolled 762 participants across 137 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Hungary, Italy, Poland, Russia, South Africa, Spain, Switzerland, United States

CollaboratorsEisai Limited

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedOct 2006

Enrollment StartNov 2006

Primary CompletionMay 2009

Study CompletionJun 2013

TodayJul 2026

First PostedOct 17, 2006

Enrollment StartNov 1, 2006

Primary CompletionMay 1, 2009

Study CompletionJun 1, 2013

TodayJul 2, 2026

Enrollment to primary: 2.5 yearsPosted 19.7 years ago

Interventions

E7389drug

1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.

Physician's Choicedrug

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.