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Brief Title: 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
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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
Study ID: NCT01663727
Brief Summary: This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
Wilshire Oncology Medical Group, Corona, California, United States
Wilshire Oncology Medical Group, Glendora, California, United States
Wilshire Oncology Medical Group, La Verne, California, United States
Long Beach Memorial Medical Center; Oncology, Long Beach, California, United States
Tenet Health System Desert Inc, Palm Springs, California, United States
Wilshire Oncology Medical Group; Oncology, Pomona, California, United States
Wilshire Oncology Medical Group, Rancho Cucamonga, California, United States
Wilshire Oncology Medical Group, West Covina, California, United States
Washington Hospital, Washington, District of Columbia, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center, Deerfield Beach, Florida, United States
Florida Cancer Specialists - Broadway, Fort Myers, Florida, United States
BRCR Medical Center, Inc., Plantation, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Northeast Georgia Cancer Care LLC, Athens, Georgia, United States
Peachtree Hematology & Oncology Consultants, Pc, Atlanta, Georgia, United States
Kaiser Foundation Hospital; Dr. Eron's Office, Honolulu, Hawaii, United States
IU Cancer Pavilion, Indianapolis, Indiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
Lahey Clinic Inc. - PARENT ACCOUNT, Burlington, Massachusetts, United States
The Jones Clinic, PC, New Albany, Mississippi, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Washington University; Center for Adv Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Signal Point Clinical; Research Center, LLC, Middletown, Ohio, United States
ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center, Sylvania, Ohio, United States
University of Toledo; Dept. of Medicine, Toledo, Ohio, United States
Virginia Cancer Specialists - Leesburg, Leesburg, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology & Hematology, Philadelphia, Pennsylvania, United States
Medical University of South Carolina; Division of Hematology-Oncology, Charleston, South Carolina, United States
SCRI-Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology-Medical City Dallas, Dallas, Texas, United States
Texas Oncology, P.A. - Dallas Presbyterian, Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth, Fort Worth, Texas, United States
Texas Oncology- Southwest Fort Worth, Fort Worth, Texas, United States
Univ of Texas Medical Branch, Galveston, Texas, United States
Texas Oncology, P.A. - Garland, Garland, Texas, United States
Cancer Care Centers of S Texas, Kerrville, Texas, United States
Texas Oncology- Longview Cancer Center, Longview, Texas, United States
Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen, McAllen, Texas, United States
Texas Oncology Plano West, Plano, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
CancerCare Centers of South Texas, San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler, The Woodlands, Texas, United States
Texas Oncology, P.A., The Woodlands, Texas, United States
Virginia Cancer Specialists - Alexandria, Alexandria, Virginia, United States
Fairfax Northern Virginia Hematology-Oncology PC, Arlington, Virginia, United States
Wellmonth Physician Services, Bristol, Virginia, United States
Virginia Oncology Associates - Chesapeake, Chesapeake, Virginia, United States
Oncology & Hematology Associates of SW Va Inc. - Market Street, Christiansburg, Virginia, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Hematology Oncology Associates of Fredericksburg, Inc., Fredericksburg, Virginia, United States
Virginia Cancer Specialists - Gainsville, Gainesville, Virginia, United States
Virginia Oncology Associates - Hampton, Hampton, Virginia, United States
Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor, Low Moor, Virginia, United States
Virginia Oncology Associates - New Port News, Newport News, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology & Hematolgy Associates of SW Va Inc. - Roanoke, Roanoke, Virginia, United States
Oncology and Hematology Assoc. of SW VA, Inc., Salem, Virginia, United States
Virginia Oncology Associates - Virginia Beach, Virginia Beach, Virginia, United States
Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville, Wytheville, Virginia, United States
Northwest Medical Specialties, PLLC; Research Department, Tacoma, Washington, United States
West Virginia University; Endocrinology, Morgantown, West Virginia, United States
Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Centro de Investigacion Pergamino SA, Pergamino, , Argentina
Instituto de Investigaciones Clínicas Quilmes, Quilmes, , Argentina
Sanatorio Parque S.A., Rosario, Santa FE, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
Instituto CAICI, Rosario, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
AZ KLINA, Brasschaat, , Belgium
UZ Brussel, Brussel, , Belgium
UZ Antwerpen, Edegem, , Belgium
GHdC Site Saint-Joseph, Gilly (Charleroi), , Belgium
CHU Ambroise Paré; Hematology and Oncology Department, Mons, , Belgium
Clinica de Tratamento e Pesquisa Oncologica - Oncotek, Brasilia, DF, Brazil
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo, RS, Brazil
Hospital Sao Lucas - PUCRS; Pesquisa Clinica, Porto Alegre, RS, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Centro de Pesquisas Oncologicas - CEPON, Florianopolis, SC, Brazil
Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Hospital das Clinicas - FMUSP Ribeirao Preto, Ribeirao Preto, SP, Brazil
Universidade Federal de Sao Paulo - UNIFESP, Sao Paulo, SP, Brazil
MHAT Dr. Tota Venkova AD, Gabrovo, , Bulgaria
SHATOD Haskovo EOOD, Haskovo, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD, Plovdiv, , Bulgaria
Complex Oncological Center - Shumen, EOOD; Department of Chemotherapy, Shumen, , Bulgaria
SHATOD - Sofia District, EOOD, Sofia, , Bulgaria
MHAT Serdika, EOOD, Sofia, , Bulgaria
UMHAT Tsaritsa Yoanna - ISUL, EAD, Sofia, , Bulgaria
SHATOD - Sofia City, EOOD, Sofia, , Bulgaria
SHATOD Dr. Marko Antonov Markov-Varna, EOOD, Varna, , Bulgaria
COC - Veliko Tarnovo, Veliko Tarnovo, , Bulgaria
Centro de Estudios Oncologicos de Santiago (CEOS) Oncologia, Santiago, , Chile
Fundacion Arturo Lopez Perez, Santiago, , Chile
Instituto Nacional del Cancer, Santiago, , Chile
Instituto Oncologico Ltda., Viña del Mar, , Chile
Studienzentrum Aschaffenburg, Aschaffenburg, , Germany
St. Johannes Hospital; Klinik fuer innere Medizin II, Onkologie, Haematologie, Dortmund, , Germany
Wilhelm-Anton-Hospital gGmbH, Goch, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
St. Elisabeth-Krankenhaus, Köln, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Azienda Ospedaliera A. Cardarelli, Napoli, Campania, Italy
Ospedale degli Infermi, Rimini, Emilia-Romagna, Italy
Ospedale Mater Salutis, Legnago (VR), Lombardia, Italy
Ospedale San Raffaele, Milano, Lombardia, Italy
Fondazione Salvatore Maugeri IRCCS, Pavia, Lombardia, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Puglia, Italy
Ospedale Versilia, Lido Di Camaiore, Toscana, Italy
NHO Shikoku Cancer Center; Dept of Respiratory Medicine, Ehime, , Japan
NHO Kyushu Cancer Center, Fukuoka, , Japan
Gifu University Hospital, Gifu, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Hyogo College of Medicine Hospital, Hyogo, , Japan
Iwate Medical University Hospital, Iwate, , Japan
Hakuaikai Sagara Hospital, Kagoshima, , Japan
Tokai University Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kumamoto City Hospital, Kumamoto, , Japan
Tohoku University Hospital, Miyagi, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
NHO Osaka National Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
NHO Hokkaido Cancer Center, Sapporo-shi, , Japan
Shizuoka General Hospital, Shizuoka-shi, , Japan
Toranomon Hospital, Tokyo, , Japan
Juntendo University Hospital, Tokyo, , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo, , Japan
National Cancer Centre, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System; Pharmacy, Seoul, , Korea, Republic of
Asan Medical Center., Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centro Hemato Oncologico Panama, Panama, , Panama
Medical Research Centre, Panama, , Panama
Institutul Oncologic "Prof. Dr. Al. Trestioreanu", Bucuresti, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie, Cluj-Napoca, , Romania
Medisprof SRL, Cluj-Napoca, , Romania
Oncomed SRL, Timisoara, , Romania
CTPI Chernihiv Regional Oncological Dispensary, Chernihiv, , Russian Federation
SHI Republican Clinical Oncological Dispensary of HM RT, Kazan, , Russian Federation
Regional Clinical Oncology Dispensary, Krasnodar, , Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF, Saint-Petersburg, , Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, , Russian Federation
Samara Regional Oncology Dispensary, Samara, , Russian Federation
Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways", St. Petersburg, , Russian Federation
National Hospital; Oncotherapy Dept, Bloemfontein, , South Africa
Cape Town Oncology Trials, Cape Town, , South Africa
Hopelands Cancer Centre Durban, Durban, , South Africa
Mary Potter Oncology Centre, Groenkloof, , South Africa
Hopelands Cancer Centre, Hilton, , South Africa
Cancercare, Port Elizabeth, , South Africa
University of Pretoria; Department of Medical Oncology, Pretoria, , South Africa
CI Cherkasy Regional Oncological Dispensary of Cherkasy RC RC of Clinical Oncology, Cherkassy, , Ukraine
CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk, , Ukraine
CCTPI Donetsk Regional Antitumor Center, Donetsk, , Ukraine
Kyiv Сity Clinical Oncological Center, Kyiv, , Ukraine
Medical and Prophylactic Institution Volyn Regional Oncological Dispensary, Lutsk, , Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU, Uzhgorod, , Ukraine
Velindre Cancer Centre, Cardiff, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital (Wonford), Exeter, , United Kingdom
Mount Vernon Hospital, Middlesex, , United Kingdom
Peterborough City Hospital, Peterborough, , United Kingdom
Derriford Hospital; Clinical Neurology Research Group, Plymouth, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR