Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and carboplatin works in treating women with operable Stage II or stage III breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)|
- pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment [ Time Frame: After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery ] [ Designated as safety issue: No ]Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery
|Study Start Date:||September 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Drug: Avastin, docetaxel, carboplatin
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208480
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Principal Investigator:||Joo Hyuk Sohn, MD, PhD||Severance Hospital|