Phase III clinical trial - Sein métastatique RH+

Sein métastatique RH+
Ouvert depuis le: 05.25.2024
Site: Saint-Cloud
Public cible
Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Description de l'essai
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).
Investigateur principal