Dr. Hershman on Misconceptions With the TAILORx Trial in HR+/HER2- Breast Cancer

Dawn L. Hershman, MD, MS, professor of medicine and epidemiology and leader of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center of Columbia University, discusses the design of the phase III TAILORx trial in hormone receptor (HR)—positive, HER2-negative breast cancer.

The TAILORx trial had an incredible impact on this space, says Hershman. This trial enrolled patients with HR-positive, HER2-negative, and axillary lymph node—negative breast cancer. Upon enrollment, the patients’ tumors were analyzed using the Oncotype Dx assay and they were assigned a risk score. Patients determined to be low risk (0-10), received hormone therapy only, while those considered to be high risk (≥26) were given hormone therapy and chemotherapy. Those with intermediate scores (11-25) were randomly assigned to receive either hormone therapy alone or hormone therapy with adjuvant chemotherapy.

The goal of the trial was to determine whether hormone therapy alone could yield outcomes that are just as favorable as those achieved with chemotherapy plus hormone therapy; the results from this trial can be confusing to some patients, says Hershman.

Sometimes patients with a lower risk score glean more benefit from hormone therapy. All the patients included in the TAILORx trial received hormonal therapy and were supposed to receive that therapy. Some patients believe that if they are low risk, they do not need chemotherapy and they might not need hormone therapy either; that is not what the results from the study indicated, stresses Hershman.

Physicians must be very careful in their messaging to patients, says Hershman. Just because a patient is determined to be low or intermediate risk, patients should not interpret that to mean that they do not require any hormone therapy or any treatment at all, concludes Hershman.