Personalized treatment goal of IU breast cancer study funded by $10 million DoD grant

04/19/04

INDIANAPOLIS – Advances in medical technology and a $10 million grant from the U.S. Department of Defense will allow researchers to study methods for individualizing treatment for women with advanced breast cancer. The funding, awarded to the Indiana University School of Medicine, is for a five-year, international study.

The grant is the maximum awarded by the Department of Defense Congressionally Directed Medical Research Programs and creates the Center of Excellence for Individualization of Therapy for Breast Cancer at the IU Cancer Center. The Hoosier Oncology Group, a consortium of oncologists, is a key participant in the study.

It is hoped that by the conclusion of the study, physicians will be able to tailor breast cancer treatments to minimize side effects while improving the response based on the patient's chemistry and tumor type.

George W. Sledge Jr., M.D., the Ballvé Lantero Professor of Oncology, is the principal investigator for the study that will utilize the skills of researchers and clinicians from across the country. Kathy Miller, M.D., assistant professor of medicine, will direct the clinical trials program.

The main objective of the study is to use the emerging technologies of genomics, proteomics and pharmacogenetics to predict individual response to standard therapeutic treatment and new drug therapies for patients with advanced breast cancer.

"Individual drugs for advanced breast cancer routinely fail to benefit the majority of women treated. As a result women with advanced disease are faced with progressively less active, progressively more toxic therapy," said Dr. Sledge. "The tragedy of modern therapy is not just its toxicity; rather, it is that so many experience so much toxicity for so little benefit."

Women being treated at multiple sites in Indiana and across the country, as well as in Canada and Peru, South America, for advanced breast cancer will be able to contribute a biopsy of their tumor and a blood sample.

Physicians affiliated with the Hoosier Oncology Group will enroll study participants. The HOG is an association of more than 400 researchers and physicians dedicated to improving therapy for cancer patients through clinical trials. The HOG was created in 1984 by oncologists at the IU Cancer Center and is now affiliated with the Walther Cancer Institute.

Tumor samples will be analyzed for their genetic composition in the laboratory of Jenny Chang, M.D., associate professor of medicine at Baylor College of Medicine. The proteins released by the tumor cells provide insight into activities and function of the cells, which can lead to new targets for developing more effective drugs. That analysis will be completed by Robert Hickey, Ph.D., associate professor of medicine, and Linda Malkas, Ph.D., Vera Bradley Professor of Oncology and professor of medicine, both at the IU School of Medicine.

Individual responses to chemotherapy agents will be tabulated by pharmacogeneticist Brian Leyland-Jones, M.D., professor of oncology at McGill University. The data will be analyzed by biostatistician Constantin Yiannoutsos, Ph.D., a statistician at the HOG and an associate professor of medicine at the IU Cancer Center.

"A decade ago, the technology that will be used by the researchers literally did not exist," said Dr. Sledge, who is a HOG investigator. "One of the benefits of a Center of Excellence grant is that it encourages collaboration with the best scientists from many universities, bringing together the best minds available to concentrate on a problem."

Using genomics, proteomics and pharmacogenetics technology, researchers will isolate the mechanisms that make tumors unique and the therapeutic agents they best respond to, producing individualized treatments.

They will seek answers to questions such as what gene is turned on to produce the malignancy, what protein controls the process and creates the resistance to drug therapy.

By identifying the tumor type and genetic profile of the patient, Dr. Sledge said it is hoped that within five years, physicians will be able to tell patients which breast cancer drugs will produce the least side effects and best action to kill the tumor cells.

Although this study will look only at patients with advanced disease, it eventually will have a direct impact on treatment for early stage breast cancer, which was diagnosed in 267,000 women in 2003, according to American Cancer Society estimates.

"In essence, we are developing the right recipe for matching the right drug to the right woman," explained Dr. Sledge.

Women with personal knowledge of the devastating disease will have a role in the research project. An important aspect of the grant, according to Dr. Sledge, is the role breast cancer advocates will play in patient education. Grant funding is available to assist with development and printing of brochures and other literature to be given to the study participants.

The groups involved are the Research Advocacy Network and the Young Survivors Coalition. Both advocacy groups played a role in determining which new drugs would be tested during the study.

"The DoD Breast Cancer Research Program is pleased to support this innovative project by Dr. Sledge, his collaborators, and the Indiana University Medical Center to address a critical issue in breast cancer - the individualization of therapy for women with breast cancer," said Colonel Kenneth A. Bertram, M.D., Ph.D., director of the Congressionally Directed Medical Research Programs. "The goal of this project is to utilize newly defined characteristics of both tumors and patients to determine tumor response to chemotherapy in order to allow patients, clinicians and researchers to develop individualized and improved treatment approaches to breast cancer."

This grant is one of several received by IU cancer researchers from the DoD program. Over the past ten years, IU medical research programs have received in excess of $22 million in funding from the DoD Congressionally Directed Medical Research Programs to investigate breast cancer and other cancer diseases.

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