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

National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP)

Status: Withdrawn

Conditions: Breast Cancer; Fatigue

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

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00914043

NSABP-B-45.1

NSABP B-45.1

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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