NEW YORK, May 24 (GenomeWeb News) - The National Cancer Institute yesterday said it has launched TAILORx, a pharmacogeomics-based trial for breast cancer treatment.
TAILORx, which stands for Trial Assigning IndividuaLized Options for Treatment, will examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate treatment.
TAILORx hopes to incorporate a molecular profiling test into clinical decision-making, sparing women from unnecessary treatments if chemotherapy would not be beneficial. The study will use Oncotype DX, a diagnostic developed by Genomic Health.
Sponsored by NCI and coordinated by the Eastern Cooperative Oncology Group, TAILORx will enroll over 10,000 women recently diagnosed with estrogen receptor or progesterone receptor positive, Her2/neu-negative breast cancer that has not yet spread to lymph nodes. The study will be conducted at 900 sites in the US and Canada.
The women will be studied for 10 years with an additional follow-up of up to 20 years after initial therapies. There will be three treatment groups: standard care (chemotherapy and hormonal therapy), hormonal therapy only, and adjuvant hormonal therapy with or without chemotherapy. Approximately 44 percent of the participants will be in the third group.