Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

481

Participants

Timeline

Start Date

August 27, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 21, 2017

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Bevacizumab [Avastin]

Intravenous repeating dose

DRUG

Paclitaxel

Intravenous repeating dose

DRUG

Placebo

Intravenous repeating dose

Trial Locations (178)

1090

UZ Brussel, Brussels

1233

SHATOD - Sofia District, EOOD, Sofia

1303

MHAT Serdika, EOOD, Sofia

1527

UMHAT Tsaritsa Yoanna - ISUL, EAD, Sofia

1784

SHATOD - Sofia City, EOOD, Sofia

1878

Instituto de Investigaciones Clínicas Quilmes, Quilmes

2000

Hospital Provincial del Centenario, Rosario

2650

UZ Antwerpen, Edegem

2930

AZ KLINA, Brasschaat

3245

Hopelands Cancer Centre, Hilton

4004

Complex Oncological Center - Plovdiv, EOOD, Plovdiv

4091

Hopelands Cancer Centre Durban, Durban

5000

COC - Veliko Tarnovo, Veliko Tarnovo

5300

MHAT Dr. Tota Venkova AD, Gabrovo

6000

GHdC Site Saint-Joseph, Gilly (Charleroi)

6045

Cancercare, Port Elizabeth

6300

SHATOD Haskovo EOOD, Haskovo

6351

Samsung Medical Center, Seoul

7000

CHU Ambroise Paré; Hematology and Oncology Department, Mons

7570

Cape Town Oncology Trials, Cape Town

9010

SHATOD Dr. Marko Antonov Markov-Varna, EOOD, Varna

9301

National Hospital; Oncotherapy Dept, Bloemfontein

9700

Complex Oncological Center - Shumen, EOOD; Department of Chemotherapy, Shumen

10408

National Cancer Centre, Gyeonggi-do

13620

Seoul National University Bundang Hospital, Gyeonggi-do

14029

CTPI Chernihiv Regional Oncological Dispensary, Chernihiv

18009

CI Cherkasy Regional Oncological Dispensary of Cherkasy RC RC of Clinical Oncology, Cherkassy

19106

Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology & Hematology, Philadelphia

20010

Washington Hospital, Washington D.C.

20132

Ospedale San Raffaele, Milan

20155

Virginia Cancer Specialists - Gainsville, Gainesville

20176

Virginia Cancer Specialists - Leesburg, Leesburg

21044

Maryland Oncology Hematology, P.A., Columbia

21204

Greater Baltimore Medical Center, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

22205

Fairfax Northern Virginia Hematology-Oncology PC, Arlington

22304

Virginia Cancer Specialists - Alexandria, Alexandria

22408

Hematology Oncology Associates of Fredericksburg, Inc., Fredericksburg

23320

Virginia Oncology Associates - Chesapeake, Chesapeake

23456

Virginia Oncology Associates - Virginia Beach, Virginia Beach

23502

Virginia Oncology Associates, Norfolk

23606

Virginia Oncology Associates - New Port News, Newport News

23666

Virginia Oncology Associates - Hampton, Hampton

24014

Oncology & Hematolgy Associates of SW Va Inc. - Roanoke, Roanoke

24073

Oncology & Hematology Associates of SW Va Inc. - Market Street, Christiansburg

24201

Wellmonth Physician Services, Bristol

24382

Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville, Wytheville

24457

Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor, Low Moor

26506

West Virginia University; Endocrinology, Morgantown

27100

Fondazione Salvatore Maugeri IRCCS, Pavia

29425

Medical University of South Carolina; Division of Hematology-Oncology, Charleston

30318

Peachtree Hematology & Oncology Consultants, Pc, Atlanta

30607

Northeast Georgia Cancer Care LLC, Athens

33322

BRCR Medical Center, Inc., Plantation

33442

Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center, Deerfield Beach

33901

Florida Cancer Specialists - Broadway, Fort Myers

34952

Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie

35294

University of Alabama at Birmingham, Birmingham

37045

Ospedale Mater Salutis, Legnago (VR)

37203

SCRI-Tennessee Oncology, Nashville

38652

The Jones Clinic, PC, New Albany

40005

RCI Sumy Regional Clinical Oncological Dispensary, Sumy

43560

ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center, Sylvania

43614

University of Toledo; Dept. of Medicine, Toledo

44137

St. Johannes Hospital; Klinik fuer innere Medizin II, Onkologie, Haematologie, Dortmund

45042

Signal Point Clinical; Research Center, LLC, Middletown

46202

IU Cancer Pavilion, Indianapolis

47574

Wilhelm-Anton-Hospital gGmbH, Goch

47923

Ospedale degli Infermi, Rimini

49102

CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

50935

St. Elisabeth-Krankenhaus, Cologne

55043

Ospedale Versilia, Lido di Camaiore

63000

Medical and Prophylactic Institution Volyn Regional Oncological Dispensary, Lutsk

63110

Washington University; Center for Adv Medicine, St Louis

63739

Studienzentrum Aschaffenburg, Aschaffenburg

65201

Missouri Cancer Associates, Columbia

69120

Universitätsklinikum Heidelberg, Heidelberg

71013

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

75093

Texas Oncology Plano West, Plano

75230

Texas Oncology-Medical City Dallas, Dallas

75231

Texas Oncology, P.A. - Dallas Presbyterian, Dallas

75601

Texas Oncology- Longview Cancer Center, Longview

76104

Texas Oncology, P.A. - Fort Worth, Fort Worth

76132

Texas Oncology- Southwest Fort Worth, Fort Worth

77060

Texas Oncology, P.A. - Garland, Garland

Texas Oncology, P.A. - Tyler, The Woodlands

Texas Oncology, P.A., The Woodlands

Oncology and Hematology Assoc. of SW VA, Inc., Salem

77555

Univ of Texas Medical Branch, Galveston

78028

Cancer Care Centers of S Texas, Kerrville

78212

Cancer Care Centers of South Texas, San Antonio

78217

Cancer Care Centers of South Texas, San Antonio

78258

CancerCare Centers of South Texas, San Antonio

78503

Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen, McAllen

79031

Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv

80131

Azienda Ospedaliera A. Cardarelli, Napoli

83092

CCTPI Donetsk Regional Antitumor Center, Donetsk

85724

Arizona Cancer Center, Tucson

88000

CCCH City Oncological Center SHEI Uzhgorod NU, Uzhhorod

89081

Universitaetsklinikum Ulm, Ulm

90806

Long Beach Memorial Medical Center; Oncology, Long Beach

91730

Wilshire Oncology Medical Group, Rancho Cucamonga

91741

Wilshire Oncology Medical Group, Glendora

91750

Wilshire Oncology Medical Group, La Verne

91767

Wilshire Oncology Medical Group; Oncology, Pomona

91790

Wilshire Oncology Medical Group, West Covina

92262

Tenet Health System Desert Inc, Palm Springs

92879

Wilshire Oncology Medical Group, Corona

96819

Kaiser Foundation Hospital; Dr. Eron's Office, Honolulu

98405

Northwest Medical Specialties, PLLC; Research Department, Tacoma

115478

"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow

195271

"Non-state Healthcare Institution Road Clinical Hospital of JSC Russian Railways", Saint Petersburg

197022

City Clinical Oncology Dispensary, Saint Petersburg

197101

SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF, Saint Petersburg

300239

Oncomed SRL, Timișoara

350040

Regional Clinical Oncology Dispensary, Krasnodar

400015

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie, Cluj-Napoca

400058

Medisprof SRL, Cluj-Napoca

420029

SHI Republican Clinical Oncological Dispensary of HM RT, Kazan'

443031

Samara Regional Oncology Dispensary, Samara

7500921

Centro de Estudios Oncologicos de Santiago (CEOS) Oncologia, Santiago

Fundacion Arturo Lopez Perez, Santiago

8380000

Instituto Nacional del Cancer, Santiago

01805

Lahey Clinic Inc. - PARENT ACCOUNT, Burlington

07601

Hackensack University Medical Center, Hackensack

C1284AEB

Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

B2700CPM

Centro de Investigacion Pergamino SA, Pergamino

S2000CVB

Instituto CAICI, Rosario

S2000KZE

Instituto de Oncología de Rosario, Rosario

S2000DSV

Sanatorio Parque S.A., Rosario, Santa FE

03000

ISIS Clinica Especializada, Santa Fe

70390-055

Clinica de Tratamento e Pesquisa Oncologica - Oncotek, Brasília

99010-260

Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo

90110-270

Hospital Sao Lucas - PUCRS; Pesquisa Clinica, Porto Alegre

90430-090

Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

88301-220

Clinica de Neoplasias Litoral, Itajaí

14048-900

Hospital das Clinicas - FMUSP Ribeirao Preto, Ribeirão Preto

22793-080

Universidade Federal de Sao Paulo - UNIFESP, São Paulo

Unknown

Instituto Oncologico Ltda., Viña del Mar

Medical Research Centre, Panama City

"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg

791-0280

NHO Shikoku Cancer Center; Dept of Respiratory Medicine, Ehime

811-1395

NHO Kyushu Cancer Center, Fukuoka

501-1194

Gifu University Hospital, Gifu

734-8551

Hiroshima University Hospital, Hiroshima

663-8501

Hyogo College of Medicine Hospital, Hyōgo

892-0833

Hakuaikai Sagara Hospital, Kagoshima

259-1193

Tokai University Hospital, Kanagawa

860-8556

Kumamoto University Hospital, Kumamoto

862-8505

Kumamoto City Hospital, Kumamoto

980-8574

Tohoku University Hospital, Miyagi

951-8566

Niigata Cancer Center Hospital, Niigata

020-8505

Iwate Medical University Hospital, Numakunai

540-0006

NHO Osaka National Hospital, Osaka

541-8567

Osaka International Cancer Institute, Osaka

589-8511

Kindai University Hospital, Osaka

003-0804

NHO Hokkaido Cancer Center, Sapporo

420-8527

Shizuoka General Hospital, Shizuoka

105-8470

Toranomon Hospital, Tokyo

113-8431

Juntendo University Hospital, Tokyo

113-8677

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo

0832

Centro Hemato Oncologico Panama, Panama City

022328

"Institutul Oncologic Prof. Dr. Al. Trestioreanu", Bucharest

0181

Mary Potter Oncology Centre, Groenkloof

0002

University of Pretoria; Department of Medical Oncology, Pretoria

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System; Pharmacy, Seoul

138-736

Asan Medical Center., Seoul

03115

Kyiv Сity Clinical Oncological Center, Kyiv

CF14 2TL

Velindre Cancer Centre, Cardiff

EH4 2XU

Western General Hospital, Edinburgh

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

HA6 2RN

Mount Vernon Hospital, Middlesex

PE3 9GZ

Peterborough City Hospital, Peterborough

PL6 8BX

Derriford Hospital; Clinical Neurology Research Group, Plymouth

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01663727 - Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter