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A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination With Bevacizumab and Paclitaxel or AMG 386 Plus Paclitaxel as First-Line Therapy in Subjects With Her2-Negative, Metastatic or Locally Recurrent Breast Cancer
Sponsor study identifier
interventional
228
13 countries
77
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
May 2014
Actual (reported)This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 2, 2007
Actual (reported)August 3, 2007
Actual (reported)August 2010
Actual (reported)May 2014
Actual (reported)Progression-free survival (PFS)
3 YEARS
Objective Response (OR)
3 YEARS
Duration of Response (DOR)
3 YEARS
Time to response
3 YEARS
Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW
Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW
Research Site
Litchfield Park, Arizona, 85340, United States
Research Site
Tucson, Arizona, 85724, United States
Research Site
Hot Springs, Arkansas, 71913, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Campbell, California, 95008, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Murrieta, California, 92562, United States
Dieras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Goncalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roche H, Sanchez-Rovira P, Pienkowski T, Segui Palmer MA, Li A, Sun YN, Pickett CA, Slamon DJ. Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study. Breast. 2015 Jun;24(3):182-90. doi: 10.1016/j.breast.2014.11.003. Epub 2015 Mar 5.
MD
Amgen
228 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2007
First Posted
August 3, 2007
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Overall Survival
3 YEARS
Time to progression (TTP)
3 YEARS
Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW
Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW
Bevacizumab 10mg/kg IV Q2W
AMG 386 10mg/kg IV QW \[Open-Label\]
AMG 386 10mg/kg IV QW \[blinded\]
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Research Site
Santa Maria, California, 93454, United States
Research Site
New Haven, Connecticut, 06520, United States
Research Site
Stamford, Connecticut, 06902, United States
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Orlando, Florida, 32804, United States
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Robbinsdale, Minnesota, 55422, United States
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Henderson, Nevada, 89052, United States
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Lebanon, New Hampshire, 03756, United States
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Nashua, New Hampshire, 03061, United States
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Edison, New Jersey, 08820, United States
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Mountain Lakes, New Jersey, 07046, United States
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Asheville, North Carolina, 28806, United States
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Charlotte, North Carolina, 28203, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19106, United States
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Columbia, South Carolina, 29210, United States
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Richardson, Texas, 75080, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77479, United States
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Ogden, Utah, 84403, United States
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Kurralta Park, South Australia, 5037, Australia
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Epping, Victoria, 3076, Australia
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Fitzroy, Victoria, 3065, Australia
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Footscray, Victoria, 3011, Australia
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Malvern, Victoria, 3144, Australia
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Perth, Western Australia, 6000, Australia
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Wels, 4600, Austria
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Wilrijk, 2610, Belgium
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Herlev, 2730, Denmark
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Helsinki, 00029, Finland
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La Roche-sur-Yon, 85925, France
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Lyon, 69008, France
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Marseille, 13009, France
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Montpellier, 34298, France
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Paris, 75020, France
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Paris, 75248, France
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Toulouse, 31052, France
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Vandœuvre-lès-Nancy, 54511, France
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Szombathely, 9700, Hungary
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Veszprém, 8200, Hungary
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Bangalore, Karnataka, 560 029, India
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Miraj, Maharashtra, 416 410, India
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Mumbai, Maharashtra, 400 012, India
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Nagpur, Maharashtra, 440 012, India
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Pune, Maharashtra, 411 001, India
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Jaipur, Rajasthan, 302 004, India
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Jaipur, Rajasthan, 302 013, India
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Maastricht, 6229 HX, Netherlands
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Gdansk, 80-952, Poland
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Lubin, 59-300, Poland
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Poznan, 61-485, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 53-413, Poland
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Jaén, AndalucÃ-a, 23007, Spain
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Sabadell, Cataluña, 08208, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Madrid, Madrid, 28033, Spain
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Guildford, GU2 7XX, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, NW1 2PG, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
Research Site
Nottingham, NG5 1PB, United Kingdom
Primary Completion
August 2010
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
October 29, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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