Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AVEO Oncology and Astellas Pharma have begun enrolling patients with advanced triple negative breast cancer in the third study, which is part of Biomarker Assessment of Tivozanib in ONcology (BATON) clinical development program.
Subscribe to our email newsletter
The double-blind, multicenter trial led by AVEO is designed to assess the efficacy profile of tivozanib combination therapy with paclitaxel against placebo combination therapy with paclitaxel in advanced or metastatic breast cancer (mBC) patients.
BATON-BC randomized study will enroll 147 locally recurrent or metastatic triple negative breast cancer patients not administered with previous mBC systemic therapy.
Astellas Pharma global development medical oncology vice president Stephen Eck said, "While tivozanib is currently under review with FDA for advanced RCC, we’re committed to investigating the development of tivozanib beyond advanced RCC."
Primary endpoint of the placebo-controlled study is progression-free survival while the objective response rate, overall survival and safety constitute the secondary objectives.
The study is designed to assess the potential tumor biomarkers that possibly respond to tivozanib in triple negative breast cancer patients.
AVEO chief medical officer William Slichenmyer said, "Biomarkers derived from AVEO’s Human Response Platform will be evaluated for potential use in identifying breast cancer patients who will be most likely to benefit from treatment with tivozanib."