Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
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|ClinicalTrials.gov Identifier: NCT01562288|
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : July 2, 2019
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis|
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||1576 participants|
|Official Title:||Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
Previously collected serum and DNA from peripheral blood mononuclear cell samples are analyzed for HER2-specific antibodies and FcγR genotype by ELISA and PCR.
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis
- disease-free survival [ Time Frame: up to 1 month ]
- overall survival [ Time Frame: up to 1 month ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562288
|Principal Investigator:||Keith L. Knutson, MD, PhD||Mayo Clinic|