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Studies & Results

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 (ROSE)

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Presentations

ASCO Annual Meeting, 2015

Mackey JR

Genetics of ramucirumab-associated hypertension in the ROSE/TRIO-012 breast cancer trial.

ASCO Annual Meeting 2015

Sambasivarao D

Relationship of germline polymorphisms to docetaxel toxicity in the ROSE/TRIO-012 trial.

San Antonio Breast Cancer Symposium, 2013

Mackey JR, Ramos-Vazquez M, Lipatov O, et al

Primary results of ROSE/TRIO-12, a randomized placebo controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer.

Publications

Spera G, Fresco R, Fung H, et al.: Beta Blockers and Improved Progression Free Survival in Patients with Advanced HER2 Negative Breast Cancer: a Retrospective Analysis of the ROSE/TRIO-012 Study. Ann Onco 28:1836-1841, 2017

Mackey JR, McCarthy N, Gelmon KA, et al: Final Survival Analysis of ROSE/TRIO-012. J Clin Oncol JCO.2016.68.9182, 2016

Lee HJ, Ryu H, Choi YS, et al: Just Toxicity, or Toxicity As a Biomarker of Efficacy of Ramucirumab in Breast Cancer? J Clin Oncol JCO.2015.60.8992, 2015

Mackey JR, Houé V, Thireau F, et al: Reply to H.J. Lee et al. J Clin Oncol JCO.2015.61.6748, 2015

Mackey JR, Ramos-Vazquez M, Lipatov O, et al: Primary Results of ROSE/TRIO-12, a Randomized Placebo-Controlled Phase III Trial Evaluating the Addition of Ramucirumab to First-Line Docetaxel Chemotherapy in Metastatic Breast Cancer. J Clin Oncol 33:141–148, 2015

Mackey J, Gelmon K, Martin M, et al: 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. Clin Breast Cancer 9:258–261, 2009

For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org