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.
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
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
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- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Panama2 sites
Centro Hemato Oncologico Panama
Panama City, 0832
Medical Research Centre
Panama City
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.
- Conditions
- Metastatic Breast Cancer
- 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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Paclitaxel + Bevacizumab [Avastin] Receives: Drug: Bevacizumab [Avastin]; Drug: Paclitaxel |
| B | Experimental | Paclitaxel + Placebo Receives: Drug: Paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
Percentage of Participants Who Died - ITT Population
Measured: From randomization till death or clinical cut-off (up to 244 weeks)
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)
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)
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)
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)
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)
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)
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)
Percentage of Participants Who Were Alive at 1 Year - ITT Population
Measured: 1 year
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.
- First posted13 Aug 2012 (estimated)
- Study start27 Aug 2012
- Primary completion30 Nov 2014
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
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
- Results posted
- Yes, on ClinicalTrials.gov
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 28158579Miles 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