Dr. Yardley on the D-CARE Trial in Women With High-Risk Early Breast Cancer

Denise A. Yardley, MD, senior investigator of breast cancer research, Sarah Cannon Research Institute, discusses the D-CARE trial in women with high-risk early breast cancer.

The D-CARE trial looked at the use of adjuvant denosumab (Xgeva) for the treatment of women with high-risk early breast cancer receiving neoadjuvant or adjuvant therapy. Yardley states that the trial failed to show benefit in bone metastasis-free survival and disease-free survival (DFS)—the primary endpoints of the study.

Researchers questioned this, as the follow-up data for the ABCSG-18 trial, looking at adjuvant denosumab in postmenopausal women with early HR-positive breast cancer, showed a DFS benefit.

Other interesting components of the trials were the side effect profiles, explains Yardley. The D-CARE trial had a very dose-intensive denosumab administration schedule with monthly doses for the first 6 months of treatment and then every 3 months thereafter for 5 years.

Yardley states that the longer patients were on treatment in the D-CARE trial, the higher the incidence of osteonecrosis of the jaw (ONJ). In the ABCSG-18 trial, there were some dental events but no ONJ events. The administration schedule in the ABCSG-18 trial was every 6 months—something that physicians utilize as a standard of care for patients who are on long-term aromatase inhibitor therapy.