Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. PURPOSE: This research study is looking at biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial NSABP-B-45.

Detailed Description
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OBJECTIVES: To collect serial blood specimens at each time point that quality of life and patient-reported outcome assessments are performed in women with residual invasive breast cancer concurrently enrolled on and participating in the Behavioral and Health Outcomes component of clinical trial NSABP-B-45. To prepare, separate, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center into components for future DNA, RNA, and plasma analysis. To analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA). To examine the association between markers of inflammation and symptoms of fatigue among patients treated with sunitinib malate or placebo on clinical trial NSABP-B-45. To examine the relationship between single-nucleotide polymorphisms in the promoter regions of IL-1 and IL-6 and symptoms of fatigue in these patients. To examine the relationship between RNA expression profiles and fatigue and compare the pattern of expression in these patients. OUTLINE: This is a multicenter study. Patients undergo blood sample collection* at baseline and then at 3, 6, 12, 18, and 24 months for analysis of plasma concentrations of inflammatory biomarkers (IL-1ra, sTNFRII, sIL-6R, and C-reactive protein) by ELISA; DNA polymorphisms in the promoter regions of IL-6 and IL-1 by TaqMan PCR; and RNA gene expression signaling pathways by RT-PCR assays and microarray. NOTE: *Blood samples are collected at the same time points that the Behavioral and Health Outcomes quality of life and patient-reported outcomes questionnaires are completed on clinical trial NSABP-B-45.

Official Title
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Biobehavioral Mechanisms of Fatigue in Patients Treated on NSABP B-45: A Phase III Clinical Trial Comparing Adjuvant Sunitinib Malate to Placebo in Women With Residual Invasive Breast Cancer Following Neoadjuvant Chemotherapy

Conditions
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Breast Cancer, Fatigue

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: polymerase chain reaction
* Genetic: polymorphism analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: biologic sample preservation procedure
* Other: enzyme-linked immunosorbent assay
* Other: laboratory biomarker analysis
* Procedure: fatigue assessment and management


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of residual invasive breast cancer Stage II, IIIA, or IIIB disease HER2/neu-negative disease Randomized to receive either sunitinib malate or placebo on clinical trial NSABP-B-45 Has not started therapy on clinical trial NSABP-B-45 Has completed baseline Behavioral and Health Outcome questionnaires on clinical trial NSABP-B-45 Hormone-receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: polymorphism analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: biologic sample preservation procedure|nan|
|Other: enzyme-linked immunosorbent assay|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: fatigue assessment and management|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological and behavioral predictors of fatigue in breast cancer patients at 12 and 24 months after randomization and initiation of treatment on clinical trial NSABP-B-45 |  |  | 
| Relationship between specific single-nucleotide polymorphisms in the promoter regions of IL-1 and IL-6 and circulating markers of inflammation and symptoms of fatigue |  |  | 
| Relationship between RNA gene expression pathways and symptoms of fatigue |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, HER2-negative breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer