Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens
- To determine the role of trastuzumab in the generation of HER2-specific antibodies in
breast cancer patients undergoing adjuvant combination therapy.
- To determine whether the improved disease-free period and overall survival of patients
treated in the adjuvant setting with combination of chemotherapy and trastuzumab is
dependent on the Fcγ receptor genotype of the patient.
OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific
antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase
chain reaction (PCR).
Magnitude of the antibody responses and the proportion of patients with an antibody response in each of the arms using ANOVA F-test followed by Tukey pairwise comparisons
Keith L. Knutson, MD, PhD
United States: Federal Government