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.
OBJECTIVES: Primary * 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. Secondary * 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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Dept. of Oncology; Rigshospitalet
Blegdamsvej, Copenhagen, Denmark
Cancer Trials Ireland Investigative Site
Dublin, Ireland
Cancer Trials Ireland Investigative Site
Dublin, Ireland
Cancer Trials Ireland Investigative Site
Dublin, Ireland
Cancer Trials Ireland Investigative Site
Galway, Ireland
Cancer Trials Ireland Investigative Site
Limerick, Ireland
Cancer Trials Ireland Investigative Site
Sligo, Ireland
Cancer Trials Ireland Investigative Site
Waterford, Ireland
Percentage of patients experiencing heart failure
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)
Time frame: 5 years
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
Non comparative efficacy by disease-free and overall survival
Time frame: 5 years
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.
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