%0 Journal Article
%A Dang, Chau
%A Ewer, Michael S
%A Delaloge, Suzette
%A Ferrero, Jean-Marc
%A Colomer, Ramon
%A de la Cruz-Merino, Luis
%A Werner, Theresa L
%A Dadswell, Katherine
%A Verrill, Mark
%A Eiger, Daniel
%A Sarkar, Sriparna
%A de Haas, Sanne Lysbet
%A Restuccia, Eleonora
%A Swain, Sandra M
%T BERENICE Final Analysis: Cardiac Safety Study of Neoadjuvant Pertuzumab, Trastuzumab, and Chemotherapy Followed by Adjuvant Pertuzumab and Trastuzumab in HER2-Positive Early Breast Cancer.
%D 2022
%@ 2072-6694
%U http://hdl.handle.net/10668/20896
%X BERENICE (NCT02132949) assessed the cardiac safety of the neoadjuvant−adjuvant pertuzumab−trastuzumab-based therapy for high-risk, HER2-positive early breast cancer (EBC). We describe key secondary objectives at final analysis. Eligible patients received dose-dense doxorubicin and cyclophosphamide q2w × 4 ➝ paclitaxel qw × 12 (Cohort A) or 5-fluorouracil, epirubicin, cyclophosphamide q3w × 4 ➝ docetaxel q3w × 4 (B) as per physician’s choice. Pertuzumab−trastuzumab (q3w) was initiated from the taxane start and continued post-surgery to complete 1 year. Median follow-up: 64.5 months. There were no new cardiac issues and a low incidence of Class III/IV heart failure (Cohort B only: one patient (0.5%) in the adjuvant and treatment-free follow-up (TFFU) periods). Fourteen patients (7.7%) had LVEF declines of ≥10% points from baseline to
%K cardiac safety
%K early breast cancer
%K neoadjuvant
%K pertuzumab
%K trastuzumab
%~