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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00687 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000726841 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Previously collected serum and DNA from peripheral blood mononuclear cell samples are analyzed for HER2-specific antibodies and FcγR genotype by ELISA and PCR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA analysis | Genetic |
| ||
| gene expression analysis |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | up to 1 month | |
| overall survival | up to 1 month |
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• Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831
* Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)
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Patients enrolled on NCCTG-N9831.
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| Name | Affiliation | Role |
|---|---|---|
| Keith L. Knutson, MD, PhD | Mayo Clinic | Principal Investigator |
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Serum and DNA extracted from peripheral blood mononuclear cell samples
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| polymerase chain reaction | Genetic |
|
| enzyme-linked immunosorbent assay | Other |
|
| laboratory biomarker analysis | Other |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D004797 | Enzyme-Linked Immunosorbent Assay |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007163 | Immunosorbent Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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