Conditions: Breast Cancer
Keywords: Cancer breast cancer neoplasm E7389 Eribulin
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 81
Healthy volunteers: no

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.

Arms:
arm 1: None

Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin mesylate 1.4 mg/m\^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.

Protocol document: