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

NCT00914043 | Withdrawn

• 2 other identifiers: NSABP B-45.1NSABP-B-45.1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Fatigue

Keywords

fatigue; HER2-negative breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

gene expression analysis GENETIC

microarray analysis GENETIC

polymerase chain reaction GENETIC

polymorphism analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

biologic sample preservation procedure OTHER

enzyme-linked immunosorbent assay OTHER

laboratory biomarker analysis OTHER

fatigue assessment and management PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Gene Expression Profiling; Microarray Analysis; Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis; Reverse Transcriptase Polymerase Chain Reaction; Enzyme-Linked Immunosorbent Assay; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Nucleic Acid Amplification Techniques; DNA Fingerprinting; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 11, 2013

Record last verified: 2013-01