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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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