Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Breast Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Bevacizumab Placebo

Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.

DRUG

Onartuzumab Placebo

Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.

Trial Locations (53)

1000

Institut Jules Bordet, Brussels

2610

Sint Augustinus Wilrijk, Wilrijk

2650

UZ Antwerpen, Edegem

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4000

CHU Sart-Tilman, Liège

7100

CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul

9000

AZ Sint Lucas (Sint Lucas), Ghent

11009

Hospital Universitario Puerta del Mar; Servicio de Oncologia, Cadiz

11733

North Shore Hem Onc Associates, East Setauket

14076

Centre Francois Baclesse; Gastro-Enterologie, Caen

15009

Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia, A Coruña

15213

Magee Womens Hospital, Pittsburgh

21079

Centre Georges Francois Leclerc; Oncologie 3, Dijon

27710

Duke University Medical Center, Durham

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29210

South Carolina Onc. Associate, Columbia

29414

Charleston Hematology Oncology, Charleston

30045

Suburban Hematology Oncology, Lawrenceville

31059

Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse

33076

Institut Bergonie; Oncologie, Bordeaux

33308

Holy Cross Hospital, Fort Lauderdale

33916

Florida Cancer Specialists; SCRI, Fort Myers

34298

Institut régional du Cancer Montpellier, Montpellier

37203

The Sarah Cannon Research Inst, Nashville

37404

SCRI Tennessee Oncology Chattanooga, Chattanooga

44805

Ico Rene Gauducheau; Oncologie, Saint-Herblain

48201

Karmanos Cancer Institute.., Detroit

60590

Klinik Johann Wolfgang von Goethe Uni, Frankfurt am Main

63739

Praxis Dr. med. Klausmann; SHOD, Aschaffenburg

69008

Centre Leon Berard, Lyon

72076

Universitätsklinik Tübingen; Frauenklinik, Tübingen

75231

Institut Curie; Oncologie Medicale, Paris

77030

MD Anderson Cancer Center, Houston

81675

Klinikum rechts der Isar der TU München; Frauenklinik, München

84403

Northern Utah Associates, Ogden

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

90095

Univ of California Los Angeles, Los Angeles

92123

Sharp Healthcare; Oncology Research Program, San Diego

92210

Centre Rene Huguenin; CONSULT SPECIALISEES, Saint-Cloud

92835

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr, Fullerton

93309

Comprehensive Blood/Cancer Ctr, Bakersfield

94589

Kaiser Permanente - Vallejo, Vallejo

95825

Kaiser Permanente Sacramento Medical Center, Sacramento

90095-1772

Can Care Assoc Med Group Inc; Beach Cities Offices, Los Angeles

67214-3728

Cancer Center of Kansas, Wichita

02114

Massachusetts General Hospital, Boston

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08907

Instituto Catalán de Oncología; Servicio de Farmacia, Barcelona

BN2 5BD

Brighton and Sussex Univ Hosp, Brighton

M20 4BX

Christie Hospital NHS Trust, Manchester

CH63 4JY

The Clatterbridge Cancer Ctr For Oncolgy, Metropolitan Borough of Wirral

HA6 2RN

Mount Vernon Hospital; Centre For Cancer Treatment, Northwood

NG5 1PB

Nottingham City Hospital; Oncology, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Genentech, Inc.

INDUSTRY