Clinical Trial Will Evaluate Individualized Treatment for Breast Cancer

The National Cancer Institute recently announced the launch of a breast cancer clinical trial called the Trial Assigning Individualized Options for Treatment (TAILORx). The trial will assess the role of the Oncotype DX™ test in guiding chemotherapy decisions among women with early breast cancer.

Although chemotherapy is recommended for many women with early-stage, node-negative breast cancer, the benefit of chemotherapy varies. Identifying in advance those women who are most likely to benefit from chemotherapy may allow for more individualized treatment. This would allow women who are unlikely to benefit from chemotherapy to avoid the toxic effects of treatment.

A gene expression test known as Oncotype DX may help guide decisions about the use of chemotherapy in women with early breast cancer. The test is indicated for patients with newly diagnosed stage I or II, node-negative, estrogen-receptor positive breast cancer who will be treated with tamoxifen. The test evaluates a panel of 21 genes to predict a patient’s 10-year risk of cancer recurrence. The test classifies patients as being at high, intermediate, or low risk of recurrence based on a Recurrence Score™. The Recurrence Score ranges from zero0 to 100, with a higher score indicating a greater risk of recurrence.

A study recently published in the Journal of Clinical Oncology reported that chemotherapy benefit among women with node-negative, estrogen receptor-positive breast cancer appeared to vary by the Oncotype DX Recurrence Score.[1] Women with a high risk of recurrence benefited from chemotherapy whereas women with a low risk of recurrence did not. The role of chemotherapy among women with an intermediate risk of recurrence remains uncertain.

To further explore the use of Oncotype DX in guiding chemotherapy decisions, the TAILORx trial will enroll more than 10,000 breast cancer patients from the United States and Canada.[2] The study will focus on breast cancer that is estrogen receptor-positive and/or progesterone receptor-positive, does not involve lymph nodes, and is Her2/neu negative.

Women in the trial will be assigned to a treatment group based on their Recurrence Score:

Women with a high Recurrence Score (greater than 25) will receive adjuvant treatment with chemotherapy plus hormonal therapy.
Women with a low Recurrence Score (less than 11) will receive adjuvant treatment with hormonal therapy alone.
Women with an intermediate Recurrence Score (from 11 to 25) will be randomly assigned to receive adjuvant treatment with either hormonal therapy alone or hormonal therapy plus chemotherapy.
The main focus of the study is the role of the Oncotype DX test in women with an intermediate risk of recurrence. In these women, the benefit of chemotherapy remains uncertain.

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[1] Paik S, Tang G, Shak S et al. Gene Expression and Benefit of Chemotherapy in Women with Node-Negative, Estrogen Receptor-Positive Breast Cancer. Journal of Clinical Oncology. Early online publication May 23, 2006.
[2] National Cancer Institute. Press Release. Personalized Treatment Trial for Breast Cancer Launched. Available at: http://www.cancer.gov/newscenter/pressreleases/TAILORxRelease. Accessed May 26, 2006.