Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Key Inclusion Criteria:

Histologically confirmed Breast cancer
Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer
refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy
At least 14 days from the completion of any previous cancer therapy
Adequate organ function
Life expectancy of 3 months or more
Willing and able to comply with the protocol and able to understand and willing to sign an informed consent

Key Exclusion Criteria:

Previously treated with eribulin
Peripheral neuropathy Grade ≥3
Receipt of prior CXCR4 therapy
Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1
History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study
Breast feeding or pregnant
Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes