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 at http://cancer.gov/clinicaltrials/ECOG-PACCT-1.

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.

Who Can Join This Trial
Researchers will enroll 10,046 women aged 18 to 75 with ER- and/or PR-positive breast cancer that has not spread to the lymph nodes and can be surgically removed. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ECOG-PACCT-1.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-PACCT-1 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.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.