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

January 10, 2013 updated by: NSABP Foundation Inc

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

January 11, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSABP B-45.1
  • NSABP-B-45.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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