TC Avastin. ICORG 08-10, V6
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 cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bevacizumab may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with docetaxel and cyclophosphamide and to see how well it works in treating patients with early-stage high-risk breast cancer.
This is a single arm, non randomised pilot study investigating the safety of the combination of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early stage, HER 2 negative, high risk breast cancer.
Procedure: adjuvant therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Evaluation of Bevacizumab, in Combination With Docetaxel and Cyclophosphamide in the Adjuvant Treatment of Patients With HER 2 Negative Breast Cancer|
- Percentage of patients experiencing heart failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Patients will be followed up through 5 years (i.e. from the time of registration through to end of Year 5 / 1 year treatment and 4 years follow up)
- Measurements of left ventricular ejection fraction by echocardiography or MUGA [ Time Frame: Sceening, day 1 of cycles 3, 5, 9, 13`.(the window of 5 days in advance to 1st day of treatment is allowed), end of treatment, follow- up annually ] [ Designated as safety issue: Yes ]
- Non comparative efficacy by disease-free and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Topo II overexpression [ Time Frame: Serum samples for assssment of Topo II overexpression collected prior to commencement of treatment, after cycle 4, at 6 months, 1 year and 12 months post last dose of bevacizumab. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Experimental: cyclophosphamide, Docetaxel, bevacizumab||Biological: bevacizumab Drug: cyclophosphamide Drug: docetaxel Procedure: adjuvant therapy|
- Assess the feasibility of the combination of adjuvant bevacizumab, docetaxel, and cyclophosphamide in patients with early-stage HER2-negative high-risk breast cancer.
- Determine the safety of this regimen with regards to cardiac toxicity, hypertension, and bleeding complications in these patients.
- Evaluate the efficacy of this regimen by measuring Topo II overexpression in these patients.
OUTLINE: This is a multicenter study.
Patients will receive 4 cycles of Docetaxel 75mg/m2 + 4 cycles of Cyclophosphamide 600mg/m2 (each cycle lasts 21 days) (+/- 3 days if a due date could not be met because of public holidays, etc) and concomitant Avastin (Bevacizumab) 15mg/kg q 3weeks for treatment duration of one year.
Bevacizumab at a dose of 15mg/kg will be administered as an intravenous infusion every 3 weeks for a treatment period of one year, regardless of missed doses.
Patients will be followed up through 5 years (i.e. from the time of registration through to end of Year 5/ 1 year treatment and 4 years follow up).
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|Dublin, Ireland, 9|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|St. James's Hospital|
|Dublin, Ireland, 8|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|Mater Private Hospital|
|Dublin, Ireland, 7|
|University College Hospital|
|Mid-Western Cancer Centre at Mid-Western Regional Hospital|
|Limerick, Ireland, 0009|
|Sligo General Hospital|
|Waterford Regional Hospital|
|Principal Investigator:||John Crown, MD||ICORG- All Ireland Cooperative Oncology Research Group|