Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
NCT ID: NCT01186991
Last Updated: 2017-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2011-03-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Onartuzumab + Bevacizumab + Paclitaxel
Participants will receive treatment with onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable drug-related toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Onartuzumab
Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.
Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.
Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m\^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
Onartuzumab + Placebo + Paclitaxel
Participants will receive treatment with onartuzumab, placebo matching to bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Onartuzumab
Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.
Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m\^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
Bevacizumab Placebo
Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Placebo + Bevacizumab + Paclitaxel
Participants will receive treatment with placebo matching to onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.
Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m\^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
Onartuzumab Placebo
Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Interventions
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Onartuzumab
Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.
Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.
Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m\^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
Bevacizumab Placebo
Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Onartuzumab Placebo
Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast
* Confirmed availability of tumor tissue
Exclusion Criteria
* Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1
* Prior therapy with a taxane for metastatic breast cancer
* Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer
* Prior therapy with hormones and/or trastuzumab
* Inadequate hematology, renal, or hepatic organ function
* Uncontrolled hypertension (systolic pressure greater than \[\>\] 150 millimeters of mercury \[mmHg\] and/or diastolic pressure \> 100 mmHg), with or without anti-hypertensive medication
* Evidence of bleeding diathesis or coagulopathy
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States
Can Care Assoc Med Group Inc; Beach Cities Offices
Los Angeles, California, United States
Univ of California Los Angeles
Los Angeles, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Sharp Healthcare; Oncology Research Program
San Diego, California, United States
Kaiser Permanente - Vallejo
Vallejo, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States
Suburban Hematology Oncology
Lawrenceville, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute..
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
North Shore Hem Onc Associates
East Setauket, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
South Carolina Onc. Associate
Columbia, South Carolina, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
The Sarah Cannon Research Inst
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Institut Jules Bordet
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, , Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Sint Augustinus Wilrijk
Wilrijk, , Belgium
Institut Bergonie; Oncologie
Bordeaux, , France
Centre Francois Baclesse; Gastro-Enterologie
Caen, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
Centre Leon Berard
Lyon, , France
Institut régional du Cancer Montpellier
Montpellier, , France
Institut Curie; Oncologie Medicale
Paris, , France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, , France
Praxis Dr. med. Klausmann; SHOD
Aschaffenburg, , Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt am Main, , Germany
Klinikum rechts der Isar der TU München; Frauenklinik
München, , Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, , Germany
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Barcelona, Spain
Instituto Catalán de Oncología; Servicio de Farmacia
Barcelona, Barcelona, Spain
Hospital Universitario Puerta del Mar; Servicio de Oncologia
Cadiz, Cadiz, Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
A Coruña, La Coruña, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Brighton and Sussex Univ Hosp
Brighton, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, , United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, , United Kingdom
Nottingham City Hospital; Oncology
Nottingham, , United Kingdom
Countries
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References
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Dieras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.
Other Identifiers
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GO01334
Identifier Type: OTHER
Identifier Source: secondary_id
2010-020101-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OAM4861g
Identifier Type: -
Identifier Source: org_study_id
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