24 February 2017 (Verona, Italy) – The statistical contributions of CROS NT to a Phase III breast cancer trial were recognized in the Journal of Clinical Oncology. CROS NT provided biostatistics methodology and analysis services for a randomized, Phase III oncology trial conducted by Novartis and Istituto Michelangelo – Femara Versus Anastrozole Clinical Evaluation (FACE).
The clinical trial compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) – positive and node-positive early breast cancer (eBC).
CROS NT’s Head of Biostatistics, Lisa Comarella, was involved as a statistician on this study. The study design consisted of a Phase IIIb, open-label, multicenter trial conducted across 271 international centers with 4,136 patients. A stratified two-sided log-rank test was used to test the treatment in terms of DFS, stratifying for number of lymph nodes and HER2 sample.
The study concluded that Letrozole did not demonstratae significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.
As a data-centric CRO, CROS NT has extensive experience in oncology trials for the collection, analysis and reporting of clinical data.