Tesetaxel + Capecitabine in HER2 Negative, HR Positive, MBC

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

March 30, 2018

  • Clinical Trial Information

    Trial Contact: Pelley, Jennifer

    Trial Phone: 321.841.4348

  • IRB No: 17.150.11

    Protocol Abbrev: ODO-TE-B301

    Principal Investigator: Regan Derek Rostorfer, MD

    Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Moroose, Rebecca MD; Shah, Nikita MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CONTESSA

    Treatment: Tesetaxel and Capecitabine

    Applicable Disease Sites: Breast

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03326674

  • Objective

    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.

  • Key Eligibility

    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.