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.

作者: John Mackey , Karen Gelmon , Miguel Martin , Nicole McCarthy , Tamas Pinter

DOI: 10.3816/CBC.2009.N.044

关键词: RamucirumabMetastatic breast cancerOncologyClinical trialBevacizumabInternal medicineDocetaxelRandomized controlled trialBreast cancerChemotherapyMedicine

摘要: In this multinational, placebo-controlled, randomized phase III trial, Translational Research 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 evaluate whether addition prolongs progression-free survival its use improves overall survival. Accrual is under way.

参考文章(17)
Bronislaw Pytowski, William O’Connor, Daniel J. Hicklin, Andrea Hooper, Yiwen Li, Karen King, Angel Santiago, Peter Bohlen, James Huber, Jay Overholser, Larry Witte, Marie Prewett, Antivascular Endothelial Growth Factor Receptor (Fetal Liver Kinase 1) Monoclonal Antibody Inhibits Tumor Angiogenesis and Growth of Several Mouse and Human Tumors Cancer Research. ,vol. 59, pp. 5209- 5218 ,(1999)
Mihaela Skobe, Patricia Rockwell, Neil Goldstein, Silvia Vosseler, Norbert E. Fusenig, Halting angiogenesis suppresses carcinoma cell invasion. Nature Medicine. ,vol. 3, pp. 1222- 1227 ,(1997) , 10.1038/NM1197-1222
Sriparna Ghosh, Catherine A.W. Sullivan, Maciej P. Zerkowski, Annette M. Molinaro, David L. Rimm, Robert L. Camp, Gina G. Chung, High levels of vascular endothelial growth factor and its receptors (VEGFR-1, VEGFR-2, neuropilin-1) are associated with worse outcome in breast cancer. Human Pathology. ,vol. 39, pp. 1835- 1843 ,(2008) , 10.1016/J.HUMPATH.2008.06.004
Miguel Martin, Tadeusz Pienkowski, John Mackey, Marek Pawlicki, Jean-Paul Guastalla, Charles Weaver, Eva Tomiak, Taher Al-Tweigeri, Linnea Chap, Eva Juhos, Raymond Guevin, Anthony Howell, Tommy Fornander, John Hainsworth, Robert Coleman, Jeferson Vinholes, Manuel Modiano, Tamas Pinter, Shou C. Tang, Bruce Colwell, Catherine Prady, Louise Provencher, David Walde, Alvaro Rodriguez-Lescure, Judith Hugh, Camille Loret, Matthieu Rupin, Sandra Blitz, Philip Jacobs, Michael Murawsky, Alessandro Riva, Charles Vogel, Adjuvant docetaxel for node-positive breast cancer. The New England Journal of Medicine. ,vol. 352, pp. 2302- 2313 ,(2005) , 10.1056/NEJMOA043681
M. Martín, A. Lluch, M.A. Seguí, A. Ruiz, M. Ramos, E. Adrover, Á. Rodríguez-Lescure, R. Grosse, L. Calvo, C. Fernandez-Chacón, M. Roset, A. Antón, D. Isla, P. Martínez del Prado, L. Iglesias, J. Zaluski, A. Arcusa, J.M. López-Vega, M. Muñoz, J.R. Mel, Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen Annals of Oncology. ,vol. 17, pp. 1205- 1212 ,(2006) , 10.1093/ANNONC/MDL135
Vernon Harvey, Henning Mouridsen, Vladimir Semiglazov, Erik Jakobsen, Edouard Voznyi, Bridget A. Robinson, Vanina Groult, Michael Murawsky, Soeren Cold, Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer Journal of Clinical Oncology. ,vol. 24, pp. 4963- 4970 ,(2006) , 10.1200/JCO.2005.05.0294
Stephen E. Jones, Michael A. Savin, Frankie Ann Holmes, Joyce A. O'Shaughnessy, Joanne L. Blum, Svetislava Vukelja, Kristi J. McIntyre, John E. Pippen, James H. Bordelon, Robert Kirby, John Sandbach, William J. Hyman, Pankaj Khandelwal, Angel G. Negron, Donald A. Richards, Stephen P. Anthony, Robert G. Mennel, Kristi A. Boehm, Walter G. Meyer, Lina Asmar, Phase III Trial Comparing Doxorubicin Plus Cyclophosphamide With Docetaxel Plus Cyclophosphamide As Adjuvant Therapy for Operable Breast Cancer Journal of Clinical Oncology. ,vol. 24, pp. 5381- 5387 ,(2006) , 10.1200/JCO.2006.06.5391
Reidun Aesoy, Betzabe Chavez Sanchez, Jens Henrik Norum, Rolf Lewensohn, Kristina Viktorsson, Barbro Linderholm, An autocrine VEGF/VEGFR2 and p38 signaling loop confers resistance to 4-hydroxytamoxifen in MCF-7 breast cancer cells. Molecular Cancer Research. ,vol. 6, pp. 1630- 1638 ,(2008) , 10.1158/1541-7786.MCR-07-2172
P.S. Hupperets, V.C. Tjan-Heijnen, Primary or secondary G-CSF prophylaxis to support TAC chemotherapy in breast cancer? Annals of Oncology. ,vol. 17, pp. 1181- 1183 ,(2006) , 10.1093/ANNONC/MDL292
Molin Wang, Julie Gralow, Maura Dickler, Melody Cobleigh, Edith A. Perez, Tamara Shenkier, David Cella, Nancy E. Davidson, Kathy Miller, Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer The New England Journal of Medicine. ,vol. 357, pp. 2666- 2676 ,(2007) , 10.1056/NEJMOA072113