A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)
OBJECTIVES:
- To determine the rate of pathological complete response in women with operable
triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and
carboplatin.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV, docetaxel IV, and carboplatin IV on day 1. Treatment repeat
every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
Patients receive docetaxel IV and carboplatin IV only during course 6. Patients undergo
surgery between weeks 19-21 as planned.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment
Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery
After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery
No
Joo Hyuk Sohn, MD, PhD
Principal Investigator
Severance Hospital
Korea: Food and Drug Administration
CDR0000685975
NCT01208480
September 2010
February 2012
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