Request Additional Trial Information
Full Trial Details: ClinicalTrials.gov
Condition: Breast Cancer
Study Type: Interventional
Phase: Phase III
Study Start Date: 01/24/18
Study Completion Date: 03/2023
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 600 patients will be enrolled.