BETHESDA, MarylandInvestigators have begun enrolling women with early-stage breast cancer in the Trial Assigning Individualized Options for Treatment (Rx), commonly referred to as TAILORx, a long-term study designed to determine whether oncologists can use the Oncotype DX (Genomic Health, Inc.) recurrence score to assign women to the most appropriate and effective adjuvant treatments. Oncotype DX measures the levels of expression of 21 specific genes in breast tumors and assigns a score from 0 to 100: The higher the score, the greater a woman's chance ofhaving a recurrence if treated with hormonal therapy alone.
The phase III NCI-supported trial seeks to accrue more than 10,000 patients at some 900 sites in the United States and Canada and one site in Peru. ECOG will coordinate the trial, which is the first launched as part of NCI's new Program for the Assessment of Clinical Cancer Tests.
"With TAILORx, we are taking a big step toward personalized medicine," said Joseph Sparano, MD, professor of medicine, Montefiore Medical Center, New York, and ECOG protocol chair.
The protocol calls for enrolling 10,046 women with histological confirmed adenocarcinoma of the breast. Participants will be studied for 10 years, and periodic follow-up will go on for up to another 20 years. Based on her Oncotype DX recurrence score, a woman will be assigned to one of three treatment groups.
•The first group, women with a recurrence score of less than 11, will receive a standard hormonal therapy for 5 or 10 yearsoral tamoxifen alone, an oral aromatase inhibitor alone, or oral tamoxifen followed by an oral aromatase inhibitorwith assignment made at the discretion of the treating physicians.
•The second group, patients with a recurrence score of 11 to 25, will be stratified by tumor size, menopausal status, and planned chemotherapy and radiotherapy. They will then be randomized to receive either the same hormonal therapy as group 1 or a standard combination chemotherapy followed 4 weeks after their last treatment by a hormonal therapy selected by the treating physician. This group will include 4,390 women, 44% of the patient population, because the degree of benefit of chemotherapy with a recurrence score of 11 to 25 remains uncertain.
•The third group, women with a recurrence score greater that 25, will undergo combination chemotherapy followed by hormonal treatment.