6:40AM AVEO Pharma and Astellas (ALPMY.PK) announce initiation of patient enrollment in Phase 2 trial of tivozanib in combination with paclitaxel in patients with advanced triple negative breast cancer (AVEO) 6.50 : Co and Astellas Pharma (ALPMY.PK) announced the initiation of patient enrollment in a randomized, double-blind, multicenter Phase 2 clinical trial, called BATON-BC, evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel compared to placebo in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer who have received no prior systemic therapy for advanced or metastatic breast cancer. BATON-BC is a double-blind, placebo-controlled, randomized (2:1 tivozanib/placebo), multicenter study that will enroll ~ 147 patients at 50 sites worldwide. The primary endpoint of BATON-BC is progression-free survival. Secondary objectives include evaluation of objective response rate, overall survival and safety. An additional component of BATON-BC is the evaluation of biomarker relationships that may be predictive of clinical response to tivozanib in patients with triple negative breast cancer.
Data from a Phase 1b clinical trial of tivozanib (0.5 mg - 1.5 mg per day for three weeks, followed by one week off, repeating at a cycle of 28 days) in combination with weekly paclitaxel (three weeks on, followed by one week off) in patients with metastatic breast cancer demonstrated that the combination was considered tolerable at the full dose and schedule of both agents (tivozanib 1.5 mg and paclitaxel 90 mg/m2), and resulted in an objective response rate of 38% (5/13 patients). In the study, 54% (7/13) of patients had stable disease (SD), with a median duration of SD of 8.5 months (range: 4.2--10.7).
Thank god because triple negative is very hard to treat (I am a recent survivor with not this type fortunately but I know others who have it) and there are NO drugs to treat it yet. This could possibly be used for early triple negative diagnosed cases...I would imagine. They usually start with advanced cases adn work their way down (like tamoxifen given to high risk now).