Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

Inclusion Criteria:

Locally recurrent or metastatic TNBC, defined as ER/PR <1%, HER2 0-1+, or 2+ with negative FISH
Measurable disease per RECIST version 1.1
ECOG performance status of 0 or 1
Confirmed available archival tumor tissue.

Exclusion Criteria:

More than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy
Prior treatment with VEGF pathway targeted agent
Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug
Known history of central nervous system metastasis (subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable off steroids or enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment may be enrolled)
Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
Significant serum chemistry or urinalysis abnormalities
Significant cardiovascular disease, including: uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to administration of first dose of study drug; and symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.
Severe peripheral neuropathy ≥ Grade 2
Currently active second primary malignancy