Elias Obeid, MD, MPH, discusses the phase 3 KATHERINE trial in HER2-positive breast cancer.
Elias Obeid, MD, MPH, interim chief, Division of Breast Medical Oncology, assistant professor, Department of Clinical Genetics, director, Breast, Ovarian, and Prostate Cancer Risk Assessment, Fox Chase Cancer Center, Temple Health, discusses the phase 3 KATHERINE trial (NCT01772472) in HER2-positive breast cancer.
KATHERINE was a 2-arm, randomized, open-label study that evaluated the efficacy and safety of ado-trastuzumab emtansine (Kadcyla; T-DM1) vs trastuzumab (Herceptin) in the adjuvant setting in patients with HER2-positive breast cancer who had residual tumor present in the breast or axillary lymph nodes following neoadjuvant chemotherapy with HER2-targeted therapy.
Patients were randomized to receive T-DM1, an antibody drug conjugate, or to continue HER2-targeted therapy, Obeid explains. If patients in the control arm were on trastuzumab alone, they would continue that as adjuvant therapy, and if patients were on trastuzumab and pertuzumab together, they would continue both treatments, Obeid elaborates.
The study met its primary end point of invasive disease-free survival, Obeid continues. Notably, the clinically meaningful results prompted investigators to unblind the trial earlier than anticipated, Obeid explains. The results of KATHERINE have been considered practice changing, Obeid concludes.