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
Clinical Trial Information
Trial Contact: Pelley, Jennifer; Jobson, Gillian S; Morales, Leticia
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 MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
Patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive, locally advanced or metastatic breast cancer (MBC) who have received no more than 1 chemotherapy regimen for advanced disease and have received a taxane in the neoadjuvant or adjuvant setting. Where indicated, patients must have received an anthracycline and endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor.