Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Status: Recruiting
Phase:
Diagnosis: Breast: Metastatic
NCT ID: NCT01745367
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-398
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer who have not received prior systemic therapy for advanced disease. Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel. Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and prior neoadjuvant or adjuvant taxane therapy (yes vs no) All subjects will be evaluated for progression free survival and overall survival as well as safety, tolerability and quality of life. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.
Conducting Institutions:
Faulkner Hospital, Dana-Farber Cancer Institute
Overall PI:
Erica Mayer, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Christina Herold,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
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:
- No prior systemic chemotherapy for treatment of metastatic breast cancer (neoadjuvant
and adjuvant therapy is allowed provided the subject did not progress and that there
is >6 months (>12 months for taxane based therapy) since end of treatment and first
dose of study drug and any toxicities have resolved to ≤ Grade 1)
- Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first
dose of study drug
- Untreated central nervous system malignancies or metastases
- 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