APHINITY is a large, randomised phase III, double-blind, placebo-controlled study that compares the efficacy and safety of chemotherapy plus trastuzumab and placebo with that of chemotherapy plus trastuzumab and pertuzumab as adjuvant therapy in approximately 4800 patients with operable, HER2-positive, primary breast cancer. Pertuzumab and trastuzumab are two drugs that target and block the HER2 protein on the cancer cells.
Several recent studies have shown that dual inhibition of the HER2 receptor with two drugs is clinically more effective than using a single agent. APHINITY is testing this hypothesis, to find out if the combination of pertuzumab and trastuzumab is better than trastuzumab alone, in terms of efficacy, for patients who have had surgery for HER2 positive breast cancer. The study aims also at exploring the safety of the combination, by looking at the potential side effects on treated patients.
The results of the primary analysis were published by New England Journal of Medicine in June 2017, with further results published in the Journal of Clinical Oncology 2021. Follow-up is ongoing and further analyses will be presented later in 2022.
PUBLICTIONS ON THE APHINITY STUDY
ESMO Open has published an article confirming the cardiac safety of adjuvant anti-HER2 treatment with pertuzumab and trastuzumab.
Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years’ follow-up
Impact of age on clinical outcomes and efficacy of adjuvant dual anti-HER2 targeted therapy