Fox Chase Cancer Center Launches Personalized Treatment Trial for Women with Breast Cancer

In an effort to accelerate the reality of “personalized medicine,” Fox Chase Cancer Center is participating in an international clinical trial designed to best determine the most appropriate and effective treatment for women with early-stage breast cancer.

The study, called TAILORx, Trial Assigning Individualized Options for Treatment (Rx), will determine whether genes frequently associated with a higher risk of breast cancer recurrence can be used to help determine the best course of treatment.

“We know from our research that some women with hormone receptor positive early stage breast cancer receive chemotherapy that is unnecessary, but the challenge is determining which women benefit and which do not,” said Lori J. Goldstein, M.D., principal investigator TAILORx at Fox Chase Cancer Center and director of Fox Chase’s Breast Evaluation Center and Breast Cancer Research Program. “TAILORx is designed to allow us to tailor a woman’s treatment based on a number of genetic factors to ensure the best course of action for each woman.”

The majority of women with hormone receptor positive early stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, yet research has demonstrated that chemotherapy does not benefit all women equally. TAILORx seeks to incorporate a molecular profiling test (a technique that examines many genes simultaneously) into clinical decision-making, and thus spare women unnecessary treatment if chemotherapy is not likely to substantially benefit them.
“This trial is important because it is one of the first to examine a methodology for personalizing cancer treatment,” said Elias A, Zerhouni, M.D., director of the National Insitutes of Health.

The study will enroll over 10,000 women at 900 sites in the United States and Canada including Fox Chase Cancer Center. Women eligible for the study will be recently diagnosed with early stage breast cancer that has not spread to the lymph nodes, and who are estrogen receptor and/or progesterone receptor positive, and Her2/neu negative.
More about TAILORx

Breast cancer is the most frequently diagnosed cancer in women, with an estimated 212,920 new cases of invasive breast cancer expected in the United States in 2006. Over one-half of these women’s cancer will test positive for estrogen receptors and will not have cancer in their lymph nodes.

“For 80 percent to 85 percent of those women, the current standard treatment practice is surgery followed by radiation and hormonal therapy,” explained Goldstein. “The proportion of women who actually benefit substantially from chemotherapy is fairly small.”
TAILORx seeks to determine the most effective approach to cancer treatment, with the fewest side effects, for women with early-stage breast cancer by using Oncotype DX™.

Oncotype DX™ measures the levels of expression of 21 genes (whether they are transcribed into messenger RNA) in breast tumors. This assessment can more precisely estimate a person’s risk of recurrence than standard characteristics, such as tumor size and grade.

Based on the Oncotype DX™ gene expression analysis, a recurrence score from 0 to 100 is generated; the higher the score, the greater a woman’s chance of having a recurrence if treated with hormonal therapy alone.

Women will be studied for 10 years, with an additional follow-up of up to 20 years after initial therapies. Based on their recurrence score, women will be assigned to three different treatment groups in the TAILORx study:

• Women with a recurrence score higher than 25 will receive chemotherapy plus hormonal therapy (the standard of care)
• Women with a recurrence score lower than 11 will receive hormonal therapy alone
• Women with a recurrence score of 11 to 25 will be randomly assigned to receive adjuvant hormonal therapy, with or without chemotherapy.
TAILORx is designed primarily to evaluate the effect of chemotherapy on those with a recurrence score of 11 to 25. Because the degree of benefit of chemotherapy for women with recurrence scores between 11 and 25 is uncertain, TAILORx seeks to determine if the Oncotype DX™ test will be helpful in future treatment planning for this group.

Hormonal therapies including tamoxifen and the aromatase inhibitors anastrozole, letrozole and exemestane are assigned based on menopausal status and comorbidities. Women on the chemotherapy arm of the trial will receive one of several standard combination chemotherapy regimens considered to be the best available standard care today. It will also be possible for women participating in TAILORx to participate in other NCI-sponsored clinical trials, provided the therapy prescribed in the clinical trial is consistent with their assigned therapy in TAILORx.

TAILORx is sponsored by the National Cancer Institute and is coordinated by the Eastern Cooperative Oncology Group.
For more information about TAILORx, call 1-888 FOX CHASE.

Fox Chase Cancer Center was founded in 1904 in Philadelphia as the nation’s first cancer hospital. In 1974, Fox Chase became one of the first institutions designated as a National Cancer Institute Comprehensive Cancer Center. Fox Chase conducts basic, clinical, population and translational research; programs of prevention, detection and treatment of cancer; and community outreach. For more information about Fox Chase activities, visit the Center’s web site at www.fccc.edu or call 1-888-FOX CHASE.