Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Biomarker/Laboratory analysis, Natural history/Epidemiology, Tissue collection/Repository | Active | 18 to 74 | NCI, Other | CDR0000694223 NSABP-NCIC-CTG-MA.32.F, NCT01286233 |
Summary
RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.
PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.
Further Study Information
OBJECTIVES:
- To prepare, separate into components, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center for future DNA, RNA, and plasma analysis, and to analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at UCLA.
- To examine the association between markers of inflammation and symptoms of fatigue among patients with and without exposure to metformin hydrochloride.
- To examine the relationship between SNPs in the promoter regions of IL-1 and IL-6 and symptoms of fatigue with and without exposure to metformin hydrochloride.
- To examine RNA expression profiles in relationship to fatigue and compare the pattern of expression in patients with and without exposure to metformin hydrochloride.
- To determine the biological and behavioral predictors of fatigue in breast cancer patients in the five years post-randomization.
- To determine whether metformin is associated with reductions in inflammatory markers and corresponding decreases in fatigue. (Exploratory)
OUTLINE: This is a multicenter study.
Patients' serum and plasma, collected at baseline and at 6, 12, and 24 months after NCIC CTG MA.32 randomization, are analyzed for inflammatory markers, DNA polymorphisms, and RNA expression arrays by ELISA, TaqMan PCR, and RT-PCR.
Patients complete the Fatigue Symptom Inventory (symptoms associated with fatigue, sleep disturbance, depression, and endocrine therapy) at baseline and periodically during study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Patient must be eligible for randomization in the NCIC-CTG-MA.32 treatment trial for breast cancer
- Participation in the NCIC-CTG-MA.32 Quality of Life (QOL) study is permitted but not required
- Patient must not have started taking NCIC-CTG-MA.32 study therapy
- Patient must have completed primary breast radiotherapy at least two weeks prior to enrollment on NSABP-NCIC-CTG-MA.32.F and is not planning to receive radiotherapy after starting NCIC-CTG-MA.32
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Patient must reside in the United States or Canada
- Patient must be English-speaking
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial Lead Organizations/Sponsors
National Surgical Adjuvant Breast and Bowel Project
National Cancer Institute| Patricia A. Ganz |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01286233
Information obtained from ClinicalTrials.gov on November 20, 2012
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