Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Depression, Insomnia Sleep Studies, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 74
Updated:4/21/2016
Start Date:July 2011
End Date:September 2016

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Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

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.

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 University of California, Los
Angeles (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 single nucleotide polymorphism (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.

Inclusion Criteria

- The patient must have consented to participate and must have signed and dated an
appropriate IRB-approved consent form that conforms to federal and institutional
guidelines for the MA.32.F Study before being enrolled.

- The patient must be female.

- The patient must reside in the United States or Canada.

- The patient must be English-speaking.

- The patient must be eligible for randomization in the MA.32 treatment trial.
(Participation in the MA.32 QOL study is permitted but not required.)

- The patient must not have started taking MA.32 study therapy.

- The patient must have completed primary breast radiation therapy at least two weeks
prior to enrollment in MA.32.F.

Exclusion Criteria

- MA.32 study therapy has been initiated.

- Currently receiving radiation therapy or additional radiation therapy is planned for
initiation after starting MA.32 study therapy.
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1900 South Avenue
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701 West 168th Street
New York, New York 10032
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San Diego, CA 92120Bus: -
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1717 S J St
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130 S Bryn Mawr Ave
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