title: 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.
abstract: OBJECTIVE
  Currently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebo-controlled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation. The ROSE/TRIO-012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer.
  
  
  METHODS
  In this double-blind, placebo-controlled, randomized, multinational phase III trial, 1,144 patients with human epidermal growth factor receptor 2 (HER2) -negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m(2) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m(2) plus placebo once every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria. Patients were stratified by previous taxane therapy, visceral metastasis, hormone receptor status, and geographic region. An independent data monitoring committee oversaw the trial. The primary end point was investigator-assessed PFS.
  
  
  RESULTS
  Median PFS in patients treated with ramucirumab plus docetaxel was 9.5 months, compared with 8.2 months in patients who received placebo plus docetaxel (hazard ratio [HR], 0.88; P = .077). Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel, compared with 27.2 months in patients who received placebo plus docetaxel (HR, 1.01; P = .915). Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue, hypertension, febrile neutropenia, palmar-plantar erythrodysesthesia syndrome, and stomatitis.
  
  
  CONCLUSIONS
  Addition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes.
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ. john.mackey@trioncology.org.
authors.forename: John R
authors.initials: JR
authors.lastname: Mackey
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos-Vazquez
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Oleg
authors.initials: O
authors.lastname: Lipatov
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Nicole
authors.initials: N
authors.lastname: McCarthy
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Dmitriy
authors.initials: D
authors.lastname: Krasnozhon
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Semiglazov
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Alexey
authors.initials: A
authors.lastname: Manikhas
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Karen A
authors.initials: KA
authors.lastname: Gelmon
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Gottfried E
authors.initials: GE
authors.lastname: Konecny
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Marc
authors.initials: M
authors.lastname: Webster
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Roberto
authors.initials: R
authors.lastname: Hegg
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Sunil
authors.initials: S
authors.lastname: Verma
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Vera
authors.initials: V
authors.lastname: Gorbunova
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Dany
authors.initials: D
authors.lastname: Abi Gerges
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Francois
authors.initials: F
authors.lastname: Thireau
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Helena
authors.initials: H
authors.lastname: Fung
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Lorinda
authors.initials: L
authors.lastname: Simms
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Marc
authors.initials: M
authors.lastname: Buyse
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Ayman
authors.initials: A
authors.lastname: Ibrahim
authors.affiliation: John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.
authors.forename: Miguel
authors.initials: M
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D064147:Febrile Neutropenia / Q000139:chemically induced; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D007074:Immunoglobulin G; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D013280:Stomatitis / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D007074:Immunoglobulin G; D043823:Taxoids; D000096662:Ramucirumab