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Clinical Trial Summary

The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.


Clinical Trial Description

This is a multicenter, single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01328249
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 2
Start date March 3, 2011
Completion date October 19, 2017

See also
  Status Clinical Trial Phase
Completed NCT01864746 - A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery Phase 3