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

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.

Inclusion Criteria:

• Histologic confirmation of invasive adenocarcinoma originating in the breast.

• Stage IV disease or Stage IIIC disease (using the 7th edition AJCC criteria) not amenable to local therapy.

• Radiographically measurable disease as per RECIST guidelines (version 1.1).

• Radiographic evidence of disease progression.

• Documentation of HER2 negative breast cancer at the time of protocol registration.

• Known hormone receptor status at the time of protocol registration.
Phase III
Cancer, All Other
Alison Conlin, M.D.
ACCRU (Academic and Community Cancer Research United)
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside
  • Oncology and Hematology Care Willamette Falls