ACCRU RU011201I A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Objective

This is a two arm Phase III trial in first- and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination.

https://www.clinicaltrials.gov/ct2/show/NCT02037529

Contact Phone: 218-786-3308 | 1-844-681-7944

Email: cancertrials@essentiahealth.org

Locations: Essentia Health Cancer Centers

Disclosures:

None

For more information about a financial conflict of interest (FCOI) or to review the Essentia Health FCOI policy, click here.

Last Updated: 06/04/2018

Research Study Categories

  • Adult Studies

Specialty

  • Cancer
  • Breast Cancer