Trial Information

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

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.