Project 1: Patients frequently report ‘fatigue’ as a consequence of breast cancer therapy but the true impact of various cancer treatments on patient’s daily activities (the amount of energy they use) and their physical fitness (ability to generate muscular power) has not been measured. Working with an exercise physiologist, Dr. Miller and her team are using state of the art technology to measure the impact of various treatments including surgery and radiation, anti-estrogen drugs, and chemotherapy during the first year after diagnosis, evaluating both the impact of acute treatment and the degree of spontaneous recovery. In addition, the study will explore the relationship of these energy parameters to changes in insulin resistance, body mass index (a measure of obesity), body composition, and patient reported physical activity, fatigue, and overall quality of life. This study provides the baseline data for individualized interventions to improve the health of breast cancer survivors. The study began enrolling patients in late 2012 and has recently amended the protocol to allow patients who receive chemotherapy and anti-estrogen treatment to enroll. The University of Wisconsin is expected to join the study team in recruiting patients by the end of 2013. During the coming year the team will complete or nearly complete the planned enrollment. As data comes in the team will begin planning the first intervention study.
Project 2: Co-Investigators: Robert L. Comis, MD, Coalition of Cancer Cooperative Groups, Philadelphia, PA and Joseph A. Sparano, MD, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY
BCRF supports The Coalition of Cancer Cooperative Groups oversees the Breast Cancer Late Relapse Biorepository, which was established in 2013 to store and catalogue biospecimens that will be collected over the next several years from women who have survived early-stage breast cancer and who had previously participated in two large cooperative group cancer treatment trials, TAILORx and E5103. The biorepository will contain primary and metastatic tumor specimens, blood specimens, and germline DNA, for example. More than 15,000 women participated in these two trials. Researchers in the CCCG will study the biospecimen collection to determine whether there are genetic differences that put women at risk for a recurrence of the disease later in their lives. Such a finding could lead to the discovery of other new drugs and treatments for patients with breast cancer in the future. In addition, the biorepository will be made available to researchers in the cooperative groups and across the scientific community.
BCRF supports offsets the costs associated with study coordinators to identify potentially eligible patients and notify the local sites where they received their treatment on a monthly basis; sites to present the sub-study and obtain consent; biospecimen distributor to ship biospecimen collection kits to the sites of consented patients; sites to collect the biospecimens and ship the samples to the central biorepository; laboratory coordination; and program management for these activities.
Project 1: During the coming year the team will complete or nearly complete the planned enrollment in their study exploring the relationship of energy parameters to changes in insulin resistance, body mass index (a measure of obesity), body composition, and patient reported physical activity, fatigue, and overall quality of life. Accrual has improved markedly since the last report, and the planned total enrollment is being increased to allow greater accuracy in the estimate of effect size and to allow subset analyses. Early data has already shown the profound physical debilitation of some patients at diagnosis and the even more dramatic impact of therapy. The team will meet in late January to begin planning the first intervention study.
Project 2: The Coalition of Cancer Cooperative Groups is overseeing the establishment of a “late-relapse biorepository,” the objective of which is to create a plasma, serum and tissue bank for evaluating determinants of late relapse of operable breast cancer. As of January 15, 2014, the effort has increased in momentum and the volume of activity has been significant. Over 700 patients have contributed more than 2400 biospecimens. Nearly 2000 biospecimen collection kits have been shipped to participating sites in preparation for the additional numbers of patients that will join the study in the coming months.
Dr. Kathy Miller is Associate Professor and Sheila D. Ward Scholar at the Indiana University School of Medicine, Division of Hematology/Oncology. She is an active member of the American Society of Clinical Oncology, the Eastern Cooperative Oncology Group and the Hoosier Oncology Group.
She received her bachelor of science degree in biology magna cum laude from the University of Miami, Coral Gables, Florida, and her medical degree from Johns Hopkins School of Medicine in Baltimore, Maryland. She completed her internship as well as her residency at Johns Hopkins School of Medicine followed by a Hematology/Oncology fellowship at Indiana University.
Her research interests focus on the role of angiogenesis in breast cancer. This interests spans departmental boundaries and has taken several forms: laboratory evaluation of the modalities that measure tumor-associated vasculature, and clinical trials of anti-angiogenic agents.