Protocol Summary Protocol No.E1105Principal InvestigatorCleary, James PhaseIII Age GroupAdultScopeNational Sponsor TypeNational Group TitleA Randomized Phase III Double Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-Expressing Metastatic Breast Cancer ObjectiveThe purpose of this study is to find out if adding an experimental medication (bevacizumab) to standard treatment increases length of survival compared to standard treatment alone. TreatmentTrastuzumab is a type of anticancer drug that is commercially available, and that has been shown to be effective in breast cancers that are positive for the protein HER-2 NEU. Bevacizumab is an investigational drug and has not yet been approved by the FDA for the treatment of breast cancer. Bevacizumab is the common name for the commercial drug Avastin. However, the bevacizumab used in this study is an investigational drug and has not yet been approved by the FDA for treatment in breast cancer. The bevacizumab that is being used in this study is for use in research studies only and may be made at locations different from those where Avastin is made.
DescriptionYou will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in any group, and you and your study doctor will NOT know which group you have been placed on. You will receive trastuzumab weekly as an infusion in the vein for four weeks. You will receive chemotherapy (paclitaxel or paclitaxel and carboplatin, based on you and your study doctor's choice as an infusion in the vein every week for 3 weeks followed by a one week rest period. In addition, if you are randomized to Arm A, you will receive a placebo for bevacizumab as an infusion in the vein once every 2 weeks, or if you are randomized to Arm B, you will receive bevacizumab, an investigational agent, as an infusion in the vein once every 2 weeks. Each 4-week period will be considered one cycle of therapy. You will receive a maximum of 6 cycles (24 weeks) of trastuzumab, chemotherapy and bevacizumab or placebo. Then, for as long as your disease does not progress and you are not experiencing any intolerable side effects, you will continue to receive trastuzumab and bevacizumab or placebo once every 3 weeks, this period of time is called "maintenance therapy."
About 489 people will take part in this study, and approximately 12-24 from the University of Wisconsin and its study sites.
Key Eligibility
- Confirmed diagnosis of breast cancer
- Evidence of metastatic disease and/or chest wall recurrence
- Overexpression of HER-2
- Prior hormone treatment allowed
- No prior chemotherapy, trastuzumab or bevacizumab allowed for metastatic disease
- No CNS metastases
Applicable Disease SitesBreast Therapies InvolvedChemotherapy Drugs InvolvedAvastin (bevacizumab)
HER2/NEU (trastuzumab)
anti-pi85 her2 monoclonal antibody (trastuzumab)
bevacizumab
carboplatin
cbdca (carboplatin)
herceptin (trastuzumab)
paclitaxel
paraplatin (carboplatin)
placebo
rhu Mab VEGF (bevacizumab)
rhuMAb HER2 (trastuzumab)
taxol (paclitaxel)
trastuzumab
Threaded Mode