Clinical trial NCT00528567: BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
Official title: An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 2591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

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.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* operable primary invasive breast cancer;
* completed definitive loco-regional surgery;
* primary tumor centrally confirmed as triple negative.

Exclusion Criteria:

* locally advanced breast cancers;
* previous breast cancer history;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Time to Invasive Disease-free Survival (IDFS) Event
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
timeFrame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
measure: Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcomes:
measure: Time to Overall Survival (OS) Event
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Time to Overall Survival (OS) Event
timeFrame: Event driven (until data cutoff: 30 June 2014: up to 77 months)
measure: Percentage of Participants With Overall Survival (OS) Event
timeFrame: Event driven (until data cut off: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Overall Survival (OS) Event
timeFrame: Event driven (until data cut off: 30 June 2014: up to 77 months)
measure: Time to Breast Cancer-Free Interval (BCFI) Event
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Time to Disease-Free Survival (DFS) Event
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Disease-Free Survival (DFS) Events
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Time to Distant Disease-Free Survival (DDFS) Event
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
timeFrame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
timeFrame: Through end of study: 30 June 2014: up to 77 months
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Fayetteville
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pleasant Hill
country: United States
state: California
city: Fairfield
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Lawrenceville
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state: Georgia
city: Niles
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state: Illinois
city: Iowa City
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state: Iowa
city: Waterloo
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state: Iowa
city: Baltimore
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state: Maryland
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state: Maryland
city: Rockville
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city: Brownstown
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state: Michigan
city: Kalamazoo
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state: Michigan
city: Southfield
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state: Michigan
city: Kansas City
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state: Missouri
city: St Louis
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state: Missouri
city: Long Branch
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state: New Jersey
city: Bronx
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state: New York
city: Hickory
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Nashville
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state: Tennessee
city: Austin
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state: Texas
city: Dallas
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state: Texas
city: Rutland
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state: Vermont
city: Abingdon
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state: Virginia
city: Richmond
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state: Virginia
city: Buenos Aires
country: Argentina
city: Rosario
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city: Brisbane
country: Australia
city: Brisbane
country: Australia
city: Camperdown
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city: East Bentleigh
country: Australia
city: Fitzroy
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city: Geelong
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city: Edmonton
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state: Alberta
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city: Vancouver
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state: British Columbia
city: Winnipeg
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state: Manitoba
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state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
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state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
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state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
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state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Greenfield Park
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state: Quebec
city: Montreal
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state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Chengdu
country: China
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country: China
city: Guangzhou
country: China
city: Hang Zhou
country: China
city: Shanghai
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city: Suzhou
country: China
city: Tianjin
country: China
city: Wuhan
country: China
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country: Costa Rica
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city: Novy Jicin
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city: Tampere
country: Finland
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city: La Chaussee St Victor
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city: Frankfurt Am Main
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city: WEIßENFELS
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city: Tel Aviv
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city: Livorno
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country: Russian Federation
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city: Persochnysaint-petersburg
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city: Ryazan
country: Russian Federation
city: Samara
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city: St Petersburg
country: Russian Federation
city: UFA
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city: Belgrade
country: Serbia
city: Sremska Kamenica
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city: Singapore
country: Singapore
city: Singapore
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city: Bloemfontein
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city: Pietermaritzburg
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
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city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Gijon
country: Spain
city: Girona
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Mataro
country: Spain
city: Málaga
country: Spain
city: Navarra
country: Spain
city: Palma de Mallorca
country: Spain
city: Pontevedra
country: Spain
city: Terrassa
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Eskilstuna
country: Sweden
city: Gaevle
country: Sweden
city: Lund
country: Sweden
city: Malmoe
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Aarau
country: Switzerland
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Chur
country: Switzerland
city: Thun
country: Switzerland
city: Winterthur
country: Switzerland
city: Zürich
country: Switzerland
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Songkhla
country: Thailand
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Brighton
country: United Kingdom
city: Bristol
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chelsmford
country: United Kingdom
city: Colchester
country: United Kingdom
city: Dundee
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Epping
country: United Kingdom
city: Exeter
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Guildford
country: United Kingdom
city: Huddersfield
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Northwood
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southampton
country: United Kingdom
city: Stoke-on-trent
country: United Kingdom
city: Truro
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.