NCI starts Oncotype DX Phase III
The National Cancer Institute started the Phase III TAILORx study in 10,046 early stage breast cancer patients to determine whether the risk of breast cancer recurrence as measured by the Oncotype DX diagnostic assay from Genomic Health (GHDX) can be used to identify the most effective treatment. In the 10-year, North American study, 4,390 patients with a recurrence score of 11 to 25 will receive adjuvant hormonal therapy with or without chemotherapy. Patients with scores higher than 25 will receive chemotherapy plus hormonal therapy, and those with scores below 11 will receive hormonal therapy alone.
The study incorporates findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) chemotherapy benefit study, which showed Oncotype DX was able to predict the magnitude of chemotherapy benefit based on recurrence score. Data were published Tuesday in the Journal of Clinical Oncology. ...