Conditions: Breast Neoplasms Breast Cancer
Keywords: Breast Cancer Metastatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 101
Healthy volunteers: no

Brief summary:
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of eribulin which is approved for the treatment of the patients in Korea with locally advanced or metastatic breast cancer who had received two to five prior chemotherapy regimens including anthracyclines and taxanes for advanced disease.

Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of investigational product is stopped, and treatment termination assessment is performed within 30 days from the last treatment.

Detailed description:

Arms:
arm 1: 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Interventions: intervention 1: Eribulin mesylate
Intervention descriptions: intervention 1: 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Protocol document: