Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer
- Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam
radiotherapy in women with HER2-overexpressing stage III or IV breast cancer.
- 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
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects experiencing adverse events
Toxicity (adverse events) will be measured and graded using the CTCAE criteria. RTOG acute toxicity criteria will be used to score acute radiation-related toxicity
Carolyn Sartor, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government