NCI Launches an Innovative Design for a Breast Cancer Clinical Trial

Extract

A new clinical trial will use a comprehensive genetic profile to test whether early-stage breast cancer patients need chemotherapy.

The National Cancer Institute–sponsored trial is among the first to tailor a patient's therapy to her individual genetic profile. Many researchers say this as yet unproven approach is a logical step in cancer treatment.

“It's very different. It's very novel because it's really testing a signature for a certain stratification of patients. It's the first time this has really been done in a treatment trial,” said James W. Jacobson, Ph.D., of NCI in Bethesda, Md.

Designed to evaluate whether women with lymph node–negative, estrogen receptor (ER)–positive, early-stage breast cancer need chemotherapy, the Trial Assigning Individualized Options for Treatment (TAILORx) uses a 21-gene test known as Oncotype DX. The test, which has been used in several recent studies, produces a genetic profile that the researchers will then use to calculate an individual's risk of breast cancer recurrence and assign patients to treatment groups. Several scientists think that this tailored approach may be a model for trial design in the future.