BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
NCT ID: NCT00528567
Last Updated: 2015-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2591 participants
INTERVENTIONAL
2007-12-31
2014-06-30
Brief Summary
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The secondary objectives of this trial are to:
* compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
* evaluate the safety and tolerability of bevacizumab
An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab and Chemotherapy
Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
Bevacizumab
Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
Standard adjuvant chemotherapy
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Chemotherapy
Participants randomized to receive standard adjuvant chemotherapy as prescribed.
Standard adjuvant chemotherapy
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Interventions
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Bevacizumab
Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
Standard adjuvant chemotherapy
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* operable primary invasive breast cancer;
* completed definitive loco-regional surgery;
* primary tumor centrally confirmed as triple negative.
Exclusion Criteria
* previous breast cancer history;
* clinically significant cardiovascular disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Huntsville, Alabama, United States
Mobile, Alabama, United States
Fayetteville, Arkansas, United States
Bakersfield, California, United States
Fountain Valley, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Pleasant Hill, California, United States
Fairfield, Connecticut, United States
Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Tamarac, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Lawrenceville, Georgia, United States
Niles, Illinois, United States
Iowa City, Iowa, United States
Waterloo, Iowa, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Brownstown, Michigan, United States
Kalamazoo, Michigan, United States
Southfield, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Long Branch, New Jersey, United States
The Bronx, New York, United States
Hickory, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Rutland, Vermont, United States
Abingdon, Virginia, United States
Richmond, Virginia, United States
Buenos Aires, , Argentina
Rosario, , Argentina
Brisbane, , Australia
Brisbane, , Australia
Camperdown, , Australia
East Bentleigh, , Australia
Fitzroy, , Australia
Geelong, , Australia
Heidelberg, , Australia
Kurralta Park, , Australia
Malvern, , Australia
Nambour, , Australia
Parkville, , Australia
Perth, , Australia
Perth, , Australia
Port Macquarie, , Australia
St Leonards, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Wahroonga, , Australia
Waratah, , Australia
Wodonga, , Australia
Wollongong, , Australia
Bludesch, , Austria
Graz, , Austria
Innsbruck, , Austria
Krems, , Austria
Leoben, , Austria
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Wels, , Austria
Wiener Neustadt, , Austria
Wolfsberg, , Austria
Baudour, , Belgium
Brussels, , Belgium
Hasselt, , Belgium
Namur, , Belgium
Sint-Niklaas, , Belgium
Tournai, , Belgium
Wilrijk, , Belgium
Sarajevo, , Bosnia and Herzegovina
Goiânia, , Brazil
Ijuí, , Brazil
Jaú, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Edmonton, Alberta, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Greater Sudbury, Ontario, Canada
Kingston, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changchun, , China
Chengdu, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Shanghai, , China
Suzhou, , China
Tianjin, , China
Wuhan, , China
Zhejiang, , China
San José, , Costa Rica
Brno, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Tampere, , Finland
Turku, , Finland
Angers, , France
Bayonne, , France
Besançon, , France
Bobigny, , France
Bordeaux, , France
Brest, , France
Clermont-Ferrand, , France
Colmar, , France
Grenoble, , France
La Chaussée-Saint-Victor, , France
Le Mans, , France
Lille, , France
Lille, , France
Limoges, , France
Marseille, , France
Montbéliard, , France
Montpellier, , France
Mougins, , France
Nancy, , France
Neuilly-sur-Seine, , France
Paris, , France
Paris, , France
Paris, , France
Rouen, , France
Saint-Cloud, , France
Senlis, , France
Strasbourg, , France
Toulon, , France
Tours, , France
Berlin, , Germany
Berlin, , Germany
Bielefeld, , Germany
Bonn, , Germany
Chemnitz, , Germany
Coburg, , Germany
Cologne, , Germany
Dortmund, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Georgsmarienhütte, , Germany
Greifswald, , Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Herne, , Germany
Kassel, , Germany
Kiel, , Germany
Krefeld, , Germany
Leipzig, , Germany
Lemgo, , Germany
Lüneburg, , Germany
Magdeburg, , Germany
Marburg, , Germany
München, , Germany
Münster, , Germany
Offenbach, , Germany
Offenburg, , Germany
Recklinghausen, , Germany
Rosenheim, , Germany
Stade, , Germany
Trier, , Germany
Tübingen, , Germany
Ulm, , Germany
Weißenfels, , Germany
Wiesbaden, , Germany
Witten, , Germany
Heraklion, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Aviano, , Italy
Bari, , Italy
Bergamo, , Italy
Brescia, , Italy
Brindisi, , Italy
Candiolo, , Italy
Cattolica, , Italy
Cesena, , Italy
Fano, , Italy
Genova, , Italy
Lecce, , Italy
Lido di Camaiore, , Italy
Livorno, , Italy
Lugo, , Italy
Mantova, , Italy
Noale, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Potenza, , Italy
Ravenna, , Italy
Rimini, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Rozzano, , Italy
San Giovanni Rotondo, , Italy
Sassari, , Italy
Taormina, , Italy
Treviglio, , Italy
Vecchiazzano, , Italy
Aichi, , Japan
Ehime, , Japan
Fukuoka, , Japan
Kyoto, , Japan
Osaka, , Japan
Saitama, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
George Town, , Malaysia
Kelantan, , Malaysia
Kuala Selangor, , Malaysia
Petaling Jaya, Selangor, , Malaysia
León, , Mexico
Monterrey, , Mexico
Delftzijl, , Netherlands
Den Helder, , Netherlands
Groningen, , Netherlands
Tilburg, , Netherlands
Auckland, , New Zealand
Wellington, , New Zealand
Skopje, , North Macedonia
Lima, , Peru
Cebu, , Philippines
Quezon City, , Philippines
Elblag, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Bucharest, , Romania
Cluj-Napoca, , Romania
Chelyabinsk, , Russia
Ivanovo, , Russia
Kazan', , Russia
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Obninsk, , Russia
Persochnysaint-petersburg, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Ufa, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Singapore, , Singapore
Singapore, , Singapore
Bloemfontein, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Pietermaritzburg, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Kyunggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
Burgos, , Spain
Gijón, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Mataró, , Spain
Málaga, , Spain
Navarra, , Spain
Palma de Mallorca, , Spain
Pontevedra, , Spain
San Cristóbal de La Laguna, , Spain
Terrassa, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Eskilstuna, , Sweden
Gävle, , Sweden
Lund, , Sweden
Malmo, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Aarau, , Switzerland
Basel, , Switzerland
Bern, , Switzerland
Chur, , Switzerland
Thun, , Switzerland
Winterthur, , Switzerland
Zurich, , Switzerland
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Songkhla, , Thailand
Belfast, , United Kingdom
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
Brighton, , United Kingdom
Bristol, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Chelsmford, , United Kingdom
Colchester, , United Kingdom
Dundee, , United Kingdom
Edinburgh, , United Kingdom
Epping, , United Kingdom
Exeter, , United Kingdom
Glasgow, , United Kingdom
Guildford, , United Kingdom
Huddersfield, , United Kingdom
Ipswich, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Merseyside, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Northwood, , United Kingdom
Peterborough, , United Kingdom
Sheffield, , United Kingdom
Southampton, , United Kingdom
Stoke-on-Trent, , United Kingdom
Truro, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.
Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.
Other Identifiers
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2007-001128-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO20289
Identifier Type: -
Identifier Source: org_study_id
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