A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alo

Clinical Trial Details

USOR 17009

A Multinational, Multicenter, 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

Purpose/Objective

Request Additional Trial Information
Full Trial Details: ClinicalTrials.gov

Condition: Breast Cancer
Study Type: Interventional
Phase: Phase III
Study Start Date: 01/24/18
Study Completion Date: 03/2023

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 an Independent Radiologic Review Committee (IRC). Approximately 600 patients will be enrolled.

NCT Number
NCT03326674
Principal Investigator(s)
Cheryl A. Aylesworth, MD
Sponsor(s)
Odonate Therapeutics, Inc.
Participant Eligibility
  • Age: 18 - No Maximum
  • Gender: Male, Female

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

Find a Doctor

Find an Adventist HealthCare affiliated doctor by calling our FREE physician referral service at 800-642-0101 or by searching our online physician directory.

View Doctors

Set Your Location

Setting your location helps us to show you nearby providers and locations based on your healthcare needs.