Dr. Tolaney on Pivotal Trials in HER2+ Breast Cancer

Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers, associate director, Susan F. Smith Center for Women's Cancers, senior physician, Dana-Farber Cancer Institute, associate professor of Medicine, Harvard Medical School, discusses pivotal trials in HER2-positive breast cancer.

Two notable practice-changing studies that have been presented in 2021 included the phase 2 DESTINY-Breast01 trial (NCT03248492) and phase 3 DESTINY-Breast03 trial (NCT03529110), Tolaney says. These 2 registration trials impacted future outcomes for patients with HER2-positive disease by leading to the approval of fam-trastuzumab deruxtecan-nxki (Enhertu), Tolaney explains. Trastuzumab deruxtecan achieved the longest progression-free survival seen in patients with metastatic HER2-positive disease, Tolaney adds.

Moreover, the phase 2 HER2CLIMB trial (NCT02614794) was the first study in the space to generate survival benefits for patients with brain metastases, Tolaney adds These data showed the presence of brain metastases must influence treatment recommendations, Tolaney says.

Data from the phase 2 DAISY trial (NCT04132960) also demonstrated that trastuzumab deruxtecan can work in HER2-0 disease, Tolaney continues. These data have shown that more to needs to be learned about the mechanism of these agents and how they can be applied to individual patients, Tolaney concludes.