MADRID – The final overall survival analysis of the CLEOPATRA trial showed an unprecedented 15.7-month increase in overall survival for women with HER2-positive metastatic breast cancer.
The results were achieved by adding pertuzumab to first-line trastuzumab and docetaxel chemotherapy (56.5 months vs. 40.8 months; hazard ratio, 0.68; P = .0002).
Importantly, the survival improvement came without excessive toxicity, including cardiac events, lead author Dr. Sandra Swain reported during a presidential symposium at the European Society for Medical Oncology Congress.
The results, now with a median follow-up of 50 months, build on those previously reported from CLEOPATRA, showing a survival trend favoring the combination of two targeted agents with chemotherapy in the first interim analysis and a statistically significant overall survival advantage at 30 months in a second interim analysis.
In a video interview at the meeting, Dr. Swain, medical director of the Washington Cancer Institute, Medstar Washington Hospital Center, discusses the results and their implications for care.