Breast Cancer, Fatigue
Conditions
Keywords
fatigue, HER2-negative breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Brief summary
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
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.
Interventions
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICpolymerase chain reaction
GENETICpolymorphism analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERbiologic sample preservation procedure
OTHERenzyme-linked immunosorbent assay
OTHERlaboratory biomarker analysis
PROCEDUREfatigue assessment and management
Sponsors
National Cancer Institute (NCI)
NSABP Foundation Inc
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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 | — |
Outcome results
None listed