AzTrials
AzTrials

Metastatic Breast CancerPhase 3NCT01663727

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

A Phase 3 study testing Bevacizumab [Avastin] and Paclitaxel in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 178 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Bevacizumab [Avastin] and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
481 participants
Where
178 sitesin 16 countries
Study dates
27 Aug 2012to 21 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

178 sites in 16 countries.

178 sites in 16 countries

United States66 sites

  • Virginia Cancer Specialists - Alexandria

    Alexandria, Virginia, 22304

  • Fairfax Northern Virginia Hematology-Oncology PC

    Arlington, Virginia, 22205

  • Northeast Georgia Cancer Care LLC

    Athens, Georgia, 30607

  • Peachtree Hematology & Oncology Consultants, Pc

    Atlanta, Georgia, 30318

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Wellmonth Physician Services

    Bristol, Virginia, 24201

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts, 01805

  • Medical University of South Carolina; Division of Hematology-Oncology

    Charleston, South Carolina, 29425

  • Virginia Oncology Associates - Chesapeake

    Chesapeake, Virginia, 23320

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

    Christiansburg, Virginia, 24073

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Wilshire Oncology Medical Group

    Corona, California, 92879

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology, P.A. - Dallas Presbyterian

    Dallas, Texas, 75231

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

    Deerfield Beach, Florida, 33442

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists - Broadway

    Fort Myers, Florida, 33901

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • Texas Oncology- Southwest Fort Worth

    Fort Worth, Texas, 76132

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408

  • Virginia Cancer Specialists - Gainsville

    Gainesville, Virginia, 20155

  • Univ of Texas Medical Branch

    Galveston, Texas, 77555

  • Texas Oncology, P.A. - Garland

    Garland, Texas, 77060

  • Wilshire Oncology Medical Group

    Glendora, California, 91741

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • Kaiser Foundation Hospital; Dr. Eron's Office

    Honolulu, Hawaii, 96819

  • IU Cancer Pavilion

    Indianapolis, Indiana, 46202

  • Cancer Care Centers of S Texas

    Kerrville, Texas, 78028

  • Wilshire Oncology Medical Group

    La Verne, California, 91750

  • Virginia Cancer Specialists - Leesburg

    Leesburg, Pennsylvania, 20176

  • Long Beach Memorial Medical Center; Oncology

    Long Beach, California, 90806

  • Texas Oncology- Longview Cancer Center

    Longview, Texas, 75601

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

    Low Moor, Virginia, 24457

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

    McAllen, Texas, 78503

  • Signal Point Clinical; Research Center, LLC

    Middletown, Ohio, 45042

  • West Virginia University; Endocrinology

    Morgantown, West Virginia, 26506

  • SCRI-Tennessee Oncology

    Nashville, Tennessee, 37203

  • The Jones Clinic, PC

    New Albany, Mississippi, 38652

  • Virginia Oncology Associates - New Port News

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Tenet Health System Desert Inc

    Palm Springs, California, 92262

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

    Philadelphia, Pennsylvania, 19106

  • Texas Oncology Plano West

    Plano, Texas, 75093

  • BRCR Medical Center, Inc.

    Plantation, Florida, 33322

  • Wilshire Oncology Medical Group; Oncology

    Pomona, California, 91767

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Wilshire Oncology Medical Group

    Rancho Cucamonga, California, 91730

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

    Roanoke, Virginia, 24014

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

    Salem, Virginia, 77060

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78212

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • CancerCare Centers of South Texas

    San Antonio, Texas, 78258

  • Washington University; Center for Adv Medicine

    St Louis, Missouri, 63110

  • ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center

    Sylvania, Ohio, 43560

  • Northwest Medical Specialties, PLLC; Research Department

    Tacoma, Washington, 98405

  • Texas Oncology, P.A. - Tyler

    The Woodlands, Texas, 77060

  • Texas Oncology, P.A.

    The Woodlands, Texas, 77060

  • University of Toledo; Dept. of Medicine

    Toledo, Ohio, 43614

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia, 23456

  • Washington Hospital

    Washington D.C., District of Columbia, 20010

  • Wilshire Oncology Medical Group

    West Covina, California, 91790

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

    Wytheville, Virginia, 24382

Other trials in United States

Japan20 sites

  • NHO Shikoku Cancer Center; Dept of Respiratory Medicine

    Ehime, 791-0280

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Gifu University Hospital

    Gifu, 501-1194

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hyogo College of Medicine Hospital

    Hyōgo, 663-8501

  • Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kumamoto City Hospital

    Kumamoto, 862-8505

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Iwate Medical University Hospital

    Numakunai, 020-8505

  • NHO Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Osaka, 589-8511

  • NHO Hokkaido Cancer Center

    Sapporo, 003-0804

  • Shizuoka General Hospital

    Shizuoka, 420-8527

  • Toranomon Hospital

    Tokyo, 105-8470

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Tokyo, 113-8677

Other trials in Japan

Bulgaria10 sites

  • MHAT Dr. Tota Venkova AD

    Gabrovo, 5300

  • SHATOD Haskovo EOOD

    Haskovo, 6300

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

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

    Shumen, 9700

  • SHATOD - Sofia District, EOOD

    Sofia, 1233

  • MHAT Serdika, EOOD

    Sofia, 1303

  • UMHAT Tsaritsa Yoanna - ISUL, EAD

    Sofia, 1527

  • SHATOD - Sofia City, EOOD

    Sofia, 1784

  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD

    Varna, 9010

  • COC - Veliko Tarnovo

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Argentina9 sites

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Instituto de Investigaciones Clínicas Quilmes

    Quilmes, 1878

  • Hospital Provincial del Centenario

    Rosario, 2000

  • Instituto CAICI

    Rosario, S2000CVB

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • Sanatorio Parque S.A.

    Rosario, Santa FE, S2000DSV

  • ISIS Clinica Especializada

    Santa Fe, 03000

Other trials in Argentina

Brazil9 sites

  • Clinica de Tratamento e Pesquisa Oncologica - Oncotek

    Brasília, Federal District, 70390-055

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

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

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital Sao Lucas - PUCRS; Pesquisa Clinica

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Clinica de Oncologia de Porto Alegre - CliniOnco

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital das Clinicas - FMUSP Ribeirao Preto

    Ribeirão Preto, São Paulo, 14048-900

  • Universidade Federal de Sao Paulo - UNIFESP

    São Paulo, São Paulo, 22793-080

Other trials in Brazil

Russia9 sites

  • CTPI Chernihiv Regional Oncological Dispensary

    Chernihiv, 14029

  • SHI Republican Clinical Oncological Dispensary of HM RT

    Kazan', 420029

  • Regional Clinical Oncology Dispensary

    Krasnodar, 350040

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways"

    Saint Petersburg, 195271

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF

    Saint Petersburg, 197101

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg

  • Samara Regional Oncology Dispensary

    Samara, 443031

Other trials in Russia

Ukraine8 sites

  • CI Cherkasy Regional Oncological Dispensary of Cherkasy RC RC of Clinical Oncology

    Cherkassy, 18009

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

    Dnipropetrovsk, 49102

  • CCTPI Donetsk Regional Antitumor Center

    Donetsk, 83092

  • Kyiv Сity Clinical Oncological Center

    Kyiv, 03115

  • Medical and Prophylactic Institution Volyn Regional Oncological Dispensary

    Lutsk, 63000

  • Lviv State Oncological Regional Treatment and Diagnostic Center

    Lviv, 79031

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005

  • CCCH City Oncological Center SHEI Uzhgorod NU

    Uzhhorod, 88000

Other trials in Ukraine

Italy7 sites

  • Ospedale Mater Salutis

    Legnago (VR), Lombardy, 37045

  • Ospedale Versilia

    Lido di Camaiore, Tuscany, 55043

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Azienda Ospedaliera A. Cardarelli

    Naples, Campania, 80131

  • Fondazione Salvatore Maugeri IRCCS

    Pavia, Lombardy, 27100

  • Ospedale degli Infermi

    Rimini, Emilia-Romagna, 47923

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

South Africa7 sites

  • National Hospital; Oncotherapy Dept

    Bloemfontein, 9301

  • Cape Town Oncology Trials

    Cape Town, 7570

  • Hopelands Cancer Centre Durban

    Durban, 4091

  • Mary Potter Oncology Centre

    Groenkloof, 0181

  • Hopelands Cancer Centre

    Hilton, 3245

  • Cancercare

    Port Elizabeth, 6045

  • University of Pretoria; Department of Medical Oncology

    Pretoria, 0002

Other trials in South Africa

Germany6 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • St. Elisabeth-Krankenhaus

    Cologne, 50935

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

    Dortmund, 44137

  • Wilhelm-Anton-Hospital gGmbH

    Goch, 47574

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea6 sites

  • National Cancer Centre

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System; Pharmacy

    Seoul, 03722

  • Asan Medical Center.

    Seoul, 138-736

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

United Kingdom6 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Derriford Hospital; Clinical Neurology Research Group

    Plymouth, PL6 8BX

Other trials in United Kingdom

Belgium5 sites

  • AZ KLINA

    Brasschaat, 2930

  • UZ Brussel

    Brussels, 1090

  • UZ Antwerpen

    Edegem, 2650

  • GHdC Site Saint-Joseph

    Gilly (Charleroi), 6000

  • CHU Ambroise Paré; Hematology and Oncology Department

    Mons, 7000

Other trials in Belgium

Chile4 sites

  • Centro de Estudios Oncologicos de Santiago (CEOS) Oncologia

    Santiago, 7500921

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921

  • Instituto Nacional del Cancer

    Santiago, 8380000

  • Instituto Oncologico Ltda.

    Viña del Mar

Other trials in Chile

Romania4 sites

  • Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

    Bucharest, 022328

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

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Panama2 sites

  • Centro Hemato Oncologico Panama

    Panama City, 0832

  • Medical Research Centre

    Panama City

Other trials in Panama

About this study

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

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.

Being tested
Bevacizumab [Avastin], Paclitaxel, Placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab [Avastin]Drug

    Intravenous repeating dose

  • PaclitaxelDrug

    Intravenous repeating dose

  • PlaceboDrug

    Intravenous repeating dose

Study groups in NCT01663727
Study groupRoleWhat they receive
AExperimentalPaclitaxel + Bevacizumab [Avastin]
Receives: Drug: Bevacizumab [Avastin]; Drug: Paclitaxel
BExperimentalPaclitaxel + Placebo
Receives: Drug: Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

  2. 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.

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

  3. 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.

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

  4. 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.

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

Secondary outcomes (10)

  1. Percentage of Participants Who Died - ITT Population

    Measured: From randomization till death or clinical cut-off (up to 244 weeks)

  2. 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.

    Measured: From randomization till death or clinical cut-off (up to 244 weeks)

  3. Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population

    Measured: From randomization till death or clinical cut-off (up to 244 weeks)

  4. 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.

    Measured: From randomization till death or clinical cut-off (up to 244 weeks)

  5. 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).

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

  6. 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.

    Measured: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

  7. 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.

    Measured: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)

  8. 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.

    Measured: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)

  9. Percentage of Participants Who Were Alive at 1 Year - ITT Population

    Measured: 1 year

  10. Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2012 (estimated)
  2. Study start27 Aug 2012
  3. Primary completion30 Nov 2014
  4. Study completion21 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01663727
Sponsor's protocol ID
GO25632
Other IDs
2011-005335-97
Status last verified
Jan 2019
First submitted
9 Aug 2012
Last updated
22 Jan 2019

Publications

  • Masuda N, Takahashi M, Nakagami K, Okumura Y, Nakayama T, Sato N, Kanatani K, Tajima K, Kashiwaba M. First-line bevacizumab plus paclitaxel in Japanese patients with HER2-negative metastatic breast cancer: subgroup results from the randomized Phase III MERiDiAN trial. Jpn J Clin Oncol. 2017 May 1;47(5):385-392. doi: 10.1093/jjco/hyx001.

    PubMed 28158579

  • Miles D, Cameron D, Bondarenko I, Manzyuk L, Alcedo JC, Lopez RI, Im SA, Canon JL, Shparyk Y, Yardley DA, Masuda N, Ro J, Denduluri N, Hubeaux S, Quah C, Bais C, O'Shaughnessy J. Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation. Eur J Cancer. 2017 Jan;70:146-155. doi: 10.1016/j.ejca.2016.09.024. Epub 2016 Nov 4.

    PubMed 27817944

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab [Avastin] and Paclitaxel in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 178 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Japan, Bulgaria, Argentina, Brazil and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population (time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01663727, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.

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