Clinical trial for newly diagnosed breast cancer patients at risk for recurrence

by: Andrew Ragsdale

University of Florida physicians at the UF Shands Cancer Center are participating in a prospective, randomized, phase III clinical trial to determine how to most effectively treat women with newly diagnosed early breast cancer utilizing a gene-expression test, the Oncotype DX™ assay. Sponsored by the National Cancer Institute and administered by the Eastern Cooperative Oncology Group, the Trial Assigning Individualized Options for Treatment (Rx) is scheduled to begin in early 2007.

Patients eligible for this trial must be women with newly diagnosed early-stage, lymph node-negative breast cancers that are estrogen and/or progesterone receptor positive and her-2 neu negative. Patients eligible for this trial represent about 25 percent of all breast cancer patients, and account for approximately 54,000 women diagnosed with breast cancer in the United States each year.

Oncotype DX™ is a gene-expression assay performed on fixed breast cancer tissue that tests for specific gene abnormalities known to be associated with relapse of breast cancer. Based on the results of a woman’s assay, a recurrence score of 0-100 is assigned and grouped into low, intermediate or high categories. Women are randomized based on their recurrence score to different treatments, including chemotherapy and/or hormonal therapy. The trial will assess various standard treatment options that yield the best survival rates with the least toxicities.

Mandy Robertson, MD, UF College of Medicine assistant professor of hematology and oncology and principal investigator of the study, said the most interesting finding from previous Oncotype DX™ studies is that women with low scores — who are less likely to have recurring cancer — seem to respond best to hormone therapy and least to chemotherapy. Conversely, previous studies suggest that women with high scores seem to respond best to chemotherapy and least to hormone therapy.

“What we don’t know is what to do for all of the women with intermediate recurrence scores,” Robertson said. “This is what we are hoping to determine with the TAILORx trial. You don’t want to unnecessarily expose women with tumors of undetermined risk of recurrence, since you don’t know the benefits of chemotherapy.”

Robertson also hopes to begin several trials in the near future that focus on neo-adjuvant (pre-operative) chemotherapy for locally advanced, inoperable breast cancers, as well as breast cancer prevention trials.

For a complete list of all available trials (updated weekly) at the UF Shands Cancer Center, visit www.ufscc.ufl.edu.

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