A Multinational, Multicenter, Randomized, Phase 3
Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane (ODO-TE-B301), NCT03326674
PURPOSE OF THIS CLINICAL RESEARCH TRIAL:
The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
Approximately 600 eligible patients will be randomly assigned in a 1:1 ratio to either Arm A (tesetaxel plus a reduced dose of capecitabine) or Arm B (approved dose of capecitabine alone).
MORE DETAILS ON THIS TRIAL:
17009 / NCT03326674 / Open 2-6-18
TRIAL AVAILABLE AT THESE LOCATIONS:
All RMCC Locations