Finding studies
Finding studies
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Lead
UNC Lineberger Comprehensive Cancer Center
With
OBJECTIVES: Primary * Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer. Secondary * Determine the pathologic response rate in patients treated with this regimen. * Determine the locoregional recurrence rate (as site of first recurrence or any recurrence) and time to locoregional recurrence in patients treated with this regimen. * Determine the time to local progression in patients (who are deemed to be non-surgical candidates) treated with this regimen . OUTLINE: This is a multicenter study. Patients receive trastuzumab IV over 30-90 minutes once a week for 5 weeks. Patients also undergo external beam radiotherapy once daily 5 days a week for 5 weeks. Three weeks after the completion of trastuzumab and radiotherapy, patients undergo surgical evaluation. Patients deemed to be surgical candidates undergo surgery. Patients deemed to be non-surgical candidates continue to receive trastuzumab and external beam radiotherapy for 2 additional weeks. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
