TRIO-012: a multicenter, multinational, randomized, double-blind phase III study of IMC-1121B plus docetaxel versus placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally recurrent or metastatic breast cancer.
Author(s): Mackey J, Gelmon K, Martin M, McCarthy N, Pinter T, Rupin M, Youssoufian H
Affiliation(s): University of Alberta and Cross Cancer Institute, Edmonton, AB, Canada. john.mackey@cirg.org
Publication date & source: 2009-11, Clin Breast Cancer., 9(4):258-61.
Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial
In this multinational, placebo-controlled, randomized phase III trial, Translational Research In Oncology (TRIO) will define the efficacy and safety of adding a novel antiangiogenic agent, IMC-1121B (ramucirumab), to standard first-line docetaxel chemotherapy for women with HER2-negative metastatic breast cancer. We will evaluate whether the addition of IMC-1121B prolongs progression-free survival and whether its use improves overall survival. Accrual is under way.
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