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

This study has been withdrawn prior to enrollment.
(Withdrawn as NCI rescinded approval for parent study NSABP-B-45)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00914043
First received: June 3, 2009
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Fatigue
 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

Study Type: Observational
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Relationship between RNA gene expression pathways and symptoms of fatigue [ Designated as safety issue: No ]

Enrollment: 0
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914043

Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

No publications provided

Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00914043     History of Changes
Other Study ID Numbers: NSABP B-45.1, NSABP-B-45.1
Study First Received: June 3, 2009
Last Updated: January 10, 2013
Health Authority: Unspecified

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
fatigue
HER2-negative breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013