Sledge The new center for excellence at the IU Cancer Center will utilize genomics, proteomics and pharmacogentetics to “tailor” a drug therapy specific to a particular patient.

By the conclusion of the study, physicians hope to be able to tailor breast cancer treatments to minimize side effects while improving the response based on the patient’s chemistry and tumor type.

Dr. George Sledge Jr., 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. Dr. Kathy Miller, assistant professor of medicine, will direct the clinical trials. The main objective of the study is to use genomics, proteomics and pharmacogenetics to predict individual response to standard therapeutic treatment and new drug therapies in 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 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, 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 Walther Cancer Institute.

“A decade ago, the technology that will be used by the researchers literally did not exist,” said Sledge. “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, 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 the 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 an estimated 267,000 women in 2003.

“In essence, we are developing the right recipe for matching the right drug to the right woman,” said Sledge.

An important aspect of the grant, he said, is the role breast cancer advocates will play in patient education. Funding is available to assist with development of brochures and other literature to be given to study participants. The groups involved are the Research Advocacy Network and the Young Survivors Coalition, both of which played a role in determining which new drugs would be tested during the study.

The grant is one of several received by IU cancer researchers from the DoD program. During the past ten years, IU medical research programs have received more than $22 million. 

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