Trial ID or NCT#

NCT03326674

Status

not recruiting iconNOT RECRUITING

Purpose

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 the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Mark Pegram
Mark Pegram
Medical oncologist, Breast specialist
Susy Yuan-Huey Hung Professor

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CONTACT

Annabel Castaneda
(650) 498-7977