Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Status:
Terminated
Trial end date:
2021-06-28
Target enrollment:
Participant gender:
Summary
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 the Independent Radiologic Review Committee
(IRC). 685 patients were enrolled.
Phase:
Phase 3
Details
Lead Sponsor:
Odonate Therapeutics, Inc. Odonate Therapeutics, LLC