Conditions: Breast Cancer
Keywords: Locally recurrent breast cancer metastatic breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 762
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: E7389 intervention 2: Physician's Choice
Intervention descriptions: intervention 1: 1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days. intervention 2: 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.

Protocol document: