Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis
|Official Title:||Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens|
- 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 [ Designated as safety issue: No ]
- Duration of disease-free survival (DFS) plotted using four Kaplan-Meier curves and interaction between arms will be investigated using Cox proportional hazards model [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562288
|Principal Investigator:||Keith L. Knutson, MD, PhD||Mayo Clinic|