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Tailored Treatment for Breast Cancer

Name of the Trial

Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal Therapy Versus Adjuvant Hormonal Therapy Alone in Women With Previously Resected Axillary Node-Negative Breast Cancer With Various Levels of Risk for Recurrence (TAILORx Trial) (ECOG-PACCT-1). See the protocol summary.

Principal Investigator

Dr. Joseph A. Sparano, Study Chair, Eastern Cooperative Oncology Group.

Why This Trial Is Important

Adding chemotherapy to hormone therapy in the adjuvant (after surgery) treatment of women with breast cancer has been shown to reduce the risk of breast cancer recurrence. However, the additional benefit provided by chemotherapy is small for women whose lymph nodes are free of disease and whose tumors are positive for the estrogen hormone receptor. Because chemotherapy can cause serious side effects, doctors want to find ways to identify patients who will benefit from chemotherapy and those who may be able to avoid it because of little added benefit.

In this trial, doctors will use a test called the Oncotype DX Breast Cancer Assay, which measures the activity of a set of genes in breast tumor tissue. Previous research has shown that a low score in this assay identifies women who will benefit little from chemotherapy, whereas those with a high score benefit substantially. More information is needed about women with scores in the middle range.

Patients will be assigned to one of three major groups. Those with Oncotype DX scores ≤10 will be treated with adjuvant hormone therapy only. Women with scores of 11 to 25 will be randomly assigned to adjuvant hormone therapy alone or adjuvant combination chemotherapy and hormone therapy. Women with scores ≥26 will be treated with adjuvant combination chemotherapy and hormone therapy.

For More Information

This study is no longer accepting new patients. To find other clinical trials for breast cancer, search the NCI's list of clinical trials or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

  • Posted: May 23, 2006
  • Updated: October 22, 2010