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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01663727
Other study ID # GO25632
Secondary ID 2011-005335-97
Status Completed
Phase Phase 3
First received
Last updated
Start date August 27, 2012
Est. completion date November 21, 2017

Study information

Verified date January 2019
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 481
Est. completion date November 21, 2017
Est. primary completion date November 30, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.

- ECOG performance status of 0 or 1

- For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception

- For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

- HER2-positive status

- Prior chemotherapy for locally recurrent or metastatic disease

- Prior hormonal therapy < 2 weeks prior to randomization

- Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization

- Investigational therapy within 28 days of randomization

General Medical Exclusions:

- Life expectancy of < 12 weeks

- Inadequate organ function

- Uncontrolled serious medical or psychiatric illness

- Active infection requiring intravenous (IV) antibiotics at screening

- Pregnancy or lactation

- History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bevacizumab [Avastin]
Intravenous repeating dose
Paclitaxel
Intravenous repeating dose
Placebo
Intravenous repeating dose

Locations

Country Name City State
Argentina 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 Hospital Provincial del Centenario Rosario
Argentina Instituto CAICI Rosario
Argentina Instituto de Oncología de Rosario Rosario
Argentina Sanatorio Parque S.A. Rosario, Santa FE
Argentina ISIS Clinica Especializada Santa Fe
Belgium 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
Brazil Clinica de Tratamento e Pesquisa Oncologica - Oncotek Brasilia DF
Brazil Centro de Pesquisas Oncologicas - CEPON Florianopolis SC
Brazil Clinica de Neoplasias Litoral Itajai SC
Brazil Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia Passo Fundo RS
Brazil Clinica de Oncologia de Porto Alegre - CliniOnco Porto Alegre RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Hospital Sao Lucas - PUCRS; Pesquisa Clinica Porto Alegre RS
Brazil Hospital das Clinicas - FMUSP Ribeirao Preto Ribeirao Preto SP
Brazil Universidade Federal de Sao Paulo - UNIFESP Sao Paulo SP
Bulgaria 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 MHAT Serdika, EOOD Sofia
Bulgaria SHATOD - Sofia City, EOOD Sofia
Bulgaria SHATOD - Sofia District, EOOD Sofia
Bulgaria UMHAT Tsaritsa Yoanna - ISUL, EAD Sofia
Bulgaria SHATOD Dr. Marko Antonov Markov-Varna, EOOD Varna
Bulgaria COC - Veliko Tarnovo Veliko Tarnovo
Chile 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
Germany 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
Italy Ospedale Mater Salutis Legnago (VR) Lombardia
Italy Ospedale Versilia Lido Di Camaiore Toscana
Italy Ospedale San Raffaele Milano Lombardia
Italy Azienda Ospedaliera A. Cardarelli Napoli Campania
Italy Fondazione Salvatore Maugeri IRCCS Pavia Lombardia
Italy Ospedale degli Infermi Rimini Emilia-Romagna
Italy Ospedale Casa Sollievo Della Sofferenza IRCCS San Giovanni Rotondo Puglia
Japan 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 City Hospital Kumamoto
Japan Kumamoto University Hospital Kumamoto
Japan Tohoku University Hospital Miyagi
Japan Niigata Cancer Center Hospital Niigata
Japan Kindai University Hospital Osaka
Japan NHO Osaka National Hospital Osaka
Japan Osaka International Cancer Institute Osaka
Japan NHO Hokkaido Cancer Center Sapporo-shi
Japan Shizuoka General Hospital Shizuoka-shi
Japan Juntendo University Hospital Tokyo
Japan Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Tokyo
Japan Toranomon Hospital Tokyo
Korea, Republic of National Cancer Centre Gyeonggi-do
Korea, Republic of Seoul National University Bundang Hospital Gyeonggi-do
Korea, Republic of Asan Medical Center. Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System; Pharmacy Seoul
Panama Centro Hemato Oncologico Panama Panama
Panama Medical Research Centre Panama
Romania 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
Russian Federation 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 FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Saint-Petersburg
Russian Federation SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF Saint-Petersburg
Russian Federation Samara Regional Oncology Dispensary Samara
Russian Federation Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways" St. Petersburg
South Africa 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
Ukraine 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 ?ity 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
United Kingdom 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 States Virginia Cancer Specialists - Alexandria Alexandria Virginia
United States Fairfax Northern Virginia Hematology-Oncology PC Arlington Virginia
United States Northeast Georgia Cancer Care LLC Athens Georgia
United States Peachtree Hematology & Oncology Consultants, Pc Atlanta Georgia
United States Greater Baltimore Medical Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Wellmonth Physician Services Bristol Virginia
United States Lahey Clinic Inc. - PARENT ACCOUNT Burlington Massachusetts
United States Medical University of South Carolina; Division of Hematology-Oncology Charleston South Carolina
United States Virginia Oncology Associates - Chesapeake Chesapeake Virginia
United States Oncology & Hematology Associates of SW Va Inc. - Market Street Christiansburg Virginia
United States Maryland Oncology Hematology, P.A. Columbia Maryland
United States Missouri Cancer Associates Columbia Missouri
United States Wilshire Oncology Medical Group Corona California
United States Texas Oncology, P.A. - Dallas Presbyterian Dallas Texas
United States Texas Oncology-Medical City Dallas Dallas Texas
United States Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center Deerfield Beach Florida
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Florida Cancer Specialists - Broadway Fort Myers Florida
United States Texas Oncology, P.A. - Fort Worth Fort Worth Texas
United States Texas Oncology- Southwest Fort Worth Fort Worth Texas
United States Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg Virginia
United States Virginia Cancer Specialists - Gainsville Gainesville Virginia
United States Univ of Texas Medical Branch Galveston Texas
United States Texas Oncology, P.A. - Garland Garland Texas
United States Wilshire Oncology Medical Group Glendora California
United States Hackensack University Medical Center Hackensack New Jersey
United States Virginia Oncology Associates - Hampton Hampton Virginia
United States Kaiser Foundation Hospital; Dr. Eron's Office Honolulu Hawaii
United States IU Cancer Pavilion Indianapolis Indiana
United States Cancer Care Centers of S Texas Kerrville Texas
United States Wilshire Oncology Medical Group La Verne California
United States Virginia Cancer Specialists - Leesburg Leesburg Pennsylvania
United States Long Beach Memorial Medical Center; Oncology Long Beach California
United States Texas Oncology- Longview Cancer Center Longview Texas
United States Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor Low Moor Virginia
United States Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen McAllen Texas
United States Signal Point Clinical; Research Center, LLC Middletown Ohio
United States West Virginia University; Endocrinology Morgantown West Virginia
United States SCRI-Tennessee Oncology Nashville Tennessee
United States The Jones Clinic, PC New Albany Mississippi
United States Virginia Oncology Associates - New Port News Newport News Virginia
United States Virginia Oncology Associates Norfolk Virginia
United States Tenet Health System Desert Inc Palm Springs California
United States Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology & Hematology Philadelphia Pennsylvania
United States Texas Oncology Plano West Plano Texas
United States BRCR Medical Center, Inc. Plantation Florida
United States Wilshire Oncology Medical Group; Oncology Pomona California
United States Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida
United States Wilshire Oncology Medical Group Rancho Cucamonga California
United States Oncology & Hematolgy Associates of SW Va Inc. - Roanoke Roanoke Virginia
United States Washington University; Center for Adv Medicine Saint Louis Missouri
United States Oncology and Hematology Assoc. of SW VA, Inc. Salem Virginia
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 ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center Sylvania Ohio
United States Northwest Medical Specialties, PLLC; Research Department Tacoma Washington
United States Texas Oncology, P.A. The Woodlands Texas
United States Texas Oncology, P.A. - Tyler The Woodlands Texas
United States University of Toledo; Dept. of Medicine Toledo Ohio
United States Arizona Cancer Center Tucson Arizona
United States Virginia Oncology Associates - Virginia Beach Virginia Beach Virginia
United States Washington Hospital Washington District of Columbia
United States Wilshire Oncology Medical Group West Covina California
United States Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville Wytheville Virginia

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Chile,  Germany,  Italy,  Japan,  Korea, Republic of,  Panama,  Romania,  Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions. Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Primary Progression Free Survival (PFS) in ITT Population PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Primary Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Primary PFS in High Baseline Plasma VEGF-A ITT Population PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Secondary Percentage of Participants Who Died - ITT Population From randomization till death or clinical cut-off (up to 244 weeks)
Secondary Overall Survival (OS) - ITT Population OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. From randomization till death or clinical cut-off (up to 244 weeks)
Secondary Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population From randomization till death or clinical cut-off (up to 244 weeks)
Secondary OS - High Baseline Plasma VEGF-A ITT Population OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. From randomization till death or clinical cut-off (up to 244 weeks)
Secondary Percentage of Participants With an Objective Response - ITT Population Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI). Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Secondary Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI. Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Secondary Duration of Response - ITT Population Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method. Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)
Secondary Duration of Response - High Baseline Plasma VEGF-A ITT Population Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method. Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)
Secondary Percentage of Participants Who Were Alive at 1 Year - ITT Population 1 year
Secondary Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population 1 year
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