NSABP NCIC CTG MA.32.F

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

Principal Investigator

Patricia Ganz, MD

Status

Complete

Disease Site

Breast [BR]

Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

 
1. To collect serial blood specimens from 454 eligible consenting female patients enrolled in the MA.32 treatment trial and MA.32.F Study at baseline and at 6, 12, and 24 months and to administer the patient-completed MA.32.F Study Questionnaire (Form SQ) and the patient-completed assessment of alcohol and tobacco use and comorbid conditions (Form MCL-B at baseline; Form MCL-F after entry) at these same time points as well as 36 months following MA.32 randomization.
 
2. 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.
 
3. To examine the association between markers of inflammation and symptoms of fatigue among patients with and without exposure to metformin.
 
4. 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.
 
5. To examine RNA expression profiles in relationship to fatigue and compare the pattern of expression in patients with and without exposure to metformin.

Patient Population

Patients enrolled in NCIC CTG MA.32 who had undergone definitive surgical treatment for invasive breast cancer within the previous 12 months were enrolled in NSABP NCIC CTG MA.32.F at the time of MA.32 randomization. 

Target Accrual

394