Breast Cancer Clinical Trial
Official title:
Phase IV Clinical Trial to Evaluate Safety of Eribulin in Patients With Locally Advanced or Metastatic Breast Cancer
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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