A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Multi-center Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in the Treatment of Subjects With Locally Recurrent and/or Metastatic Triple Negative Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 and over, Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01745367
Protocol IDs
AV-951-12-204 (primary)
2012-003507-35
Study Sponsor
AVEO Pharmaceuticals, Incorporated

Summary

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.

Treatment Sites in Georgia


Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu