Refining and identifying new biomarkers for risk to better personalize therapeutic strategies in early-stage breast cancer.

Impact

The RxPONDER clinical trial was immensely valuable for identifying the right treatment for patients with early-stage hormone receptor (HR)-positive, HER2-negative breast cancer. In the study, patients were defined by their recurrence score which was calculated based on the results of a genomic test called OncotypeDX®. In those who had a low recurrence score (less than 25), the study found no added benefit of chemotherapy in postmenopausal patients whose cancer had spread to three or fewer lymph nodes. In premenopausal women the opposite was true, they benefitted from chemotherapy. This study was groundbreaking, and Dr. Kalinsky and his team will pursue further research to build upon its findings and make its results more universal and accessible for patients. 

What’s next

The team will pursue two separate questions in their study. The first will reassess how menopause is classified in patients. In RxPONDER, menopausal status was based upon self-reported menstrual history, but this can be an imperfect measure. The team will instead explore if menopause can be defined by hormone levels measured in RxPonder patient samples prior to start of treatment. They will evaluate if patient outcomes differ based on the criteria used to define menopause: blood hormone levels versus menstrual history. In the second part of their study, the team will test an alternative method for identifying recurrence scores, as OncotypeDX® is an expensive, laboratory-based test. They will use a computer-aided diagnosis method called CHIP, which generates a risk score based on image analysis of tumor samples for unique cellular arrangements and characteristics. Ultimately, the team will assess if a CHIP recurrence score might be a less costly alternative to OncotypeDx®.