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Trial information
BEATRICE study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer.
Status: Recruiting
Protocol number: BO20289
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label 2-arm study to evaluate the impact of adjuvant bevacizumab on Invasive Disease Free Survival in triple negative breast cancer
Brief summary: This 2 arm open-label study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin (5mg/kg/week dosing equivalent i.v.). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is
2530.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Invasive disease-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall survival, breast cancer-free interval, disease-free interval, distant disease-free survival. Time frame: Event driven.
2. AEs, and laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2007
Trial registration date: 09/11/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:Argentina Australia - Adelaide
- Brisbane
- Fitzroy
- Geelong
- Heidelberg
- Malvern
- Melbourne
- Nambour
- Parkville
- Perth
- Port Macquarie
- St. Leonards
- Sydney
- Waratah
- Wodonga
- Wollongong
Austria - Bludesch
- Graz
- Innsbruck
- Leoben
- Salzburg
- Wels
- Wien
- Wiener Neustadt
- Wolfsberg
Belgium - Baudour
- Bruxelles
- Hasselt
- Sint-Niklaas
- Wilrijk
Bosnia and Herzegovina Brazil - Jaú
- Porto Alegre
- Porto Alegre Rs
- Rio De Janeiro
- Santo Andre
- Sao Paulo
Canada - Edmonton, AB
- Surrey, BC
- Vancouver, BC
- Winnipeg, MB
- Moncton, NB
- St John'S
- Halifax, NS
- Kingston, ON
- Kitchener, ON
- London, ON
- Mississauga, ON
- Oshawa, ON
- Ottawa, ON
- Sudbury, ON
- Toronto, ON
- Windsor, ON
- Greenfield Park, QC
- Montreal, QC
- Quebec City, QC
- Saskatoon, SK
China Costa Rica Czech Republic - Brno
- Novy Jicin
- Olomouc
- Pardubice
- Praha
Finland France - Angers
- Bayonne
- Besancon
- Bobigny
- Bordeaux
- Brest
- Chaussée Saint Victor
- Clermont-Ferrand
- Colmar
- Grenoble
- Le Mans
- Lille
- Limoges
- Marseille
- Montbeliard
- Montpellier
- Mougins
- Nancy
- Neuilly-Sur-Seine
- Paris
- Rouen
- Saint-Cloud
- Senlis
- Strasbourg
- Toulon
- Tours
Germany - Berlin
- Bielefeld
- Chemnitz
- Coburg
- Dortmund
- Dresden
- Frankfurt Am Main
- Freiburg
- Georgsmarienhütte
- Greifswald
- Hamburg
- Heidelberg
- Herne
- Kassel
- Kiel
- Köln
- Krefeld
- Leipzig
- Lemgo
- Magdeburg
- Marburg
- München
- Münster
- Offenbach
- Recklinghausen
- Rosenheim
- Stade
- Trier
- Tübingen
- Ulm
- Weissenfels
- Witten
Greece - Heraklion
- Patras
- Thessaloniki
Israel - Haifa
- Jerusalem
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Rehovot
- Tel Aviv
Italy - Aviano
- Bari
- Bergamo
- Brescia
- Brindisi
- Candiolo
- Cattolica
- Cesena
- Fano
- Genova
- Lecce
- Lido Di Camaiore
- Livorno
- Noale
- Palermo
- Parma
- Pavia
- Potenza
- Ravenna
- Ravenna, Emilia Romagna
- Rimini
- Roma
- Rozzano
- San Giovanni Rotondo
- Sassari
- Taormina
- Treviglio
- Vecchiazzano
Japan - Aichi
- Fukuoka
- Kyoto
- Matsuyama-Shi, Ehime
- Osaka
- Saitama
- Tokyo
Macedonia, The Former Yugoslav Republic of Malaysia - Kelantan
- Kuala Lumpur
- Penang
- Petaling Jaya, Selangor
- Selangor
Mexico Netherlands - Delftzijl
- Den Helder
- Groningen
- Tilburg
New Zealand Peru Philippines Poland - Elblag
- Lodz
- Lublin
- Poznan
- Warszawa
Portugal Romania Russian Federation - Chelyabinsk
- Ekaterinburg
- Ivanovo
- Kazan
- Moscow
- Obninsk
- Ryazan
- Samara
- St Petersburg
- Ufa
Singapore South Africa - Bloemfontein
- Durban
- Johannesburg
- Pietermaritzburg
- Pretoria
Spain - Barcelona
- Burgos
- Gijon
- Girona
- La Laguna
- Madrid
- Malaga
- Mataro
- Navarra
- Palma de Mallorca
- Pontevedra
- Terrassa
- Valencia
- Zaragoza
Sweden - Gaevle
- Lund
- Malmoe
- Umea
- Uppsala
Switzerland - Aarau
- Basel
- Bern
- Chur
- Thun
- Winterthur
- Zuerich
Taiwan - Changhua
- Kaohsiung
- Tainan
- Taipei
- Taoyuan
Thailand - Bangkok
- Chiang Mai
- Songkhla
United Kingdom - Belfast
- Birmingham
- Bournemouth
- Brighton
- Bristol
- Cambridge
- Cardiff
- Chelsmford
- Colchester
- Dundee
- Edinburgh
- Epping
- Exeter
- Glasgow
- Guildford
- Huddersfield
- Leeds
- London
- Manchester
- Merseyside
- Newcastle upon Tyne
- Northwood
- Peterborough
- Sheffield
- Stoke-on-Trent
- Truro
- Wolverhampton
United States - Huntsville, AL
- Mobile, AL
- Fayetteville, AR
- Bakersfield, CA
- Fountain Valley, CA
- Greenbrae, CA
- Los Angeles, CA
- Pleasant Hill, CA
- Fairfield, CT
- Stamford, CT
- Washington, DC
- Gainesville, FL
- Orlando, FL
- Tamarac, FL
- Atlanta, GA
- Augusta, GA
- Lawrenceville, GA
- Park Ridge, IL
- Iowa City, IA
- Waterloo, IA
- Baltimore, MD
- Rockville, MD
- Kalamazoo, MI
- Southfield, MI
- Woodhaven, MI
- Kansas City, MO
- St Louis, MO
- Long Branch, NJ
- Bronx, NY
- Hickory , NC
- Cincinnati, OH
- Columbus, OH
- Middletown, OH
- Columbia, SC
- Chatanooga, TN
- Germantown, TN
- Nashville, TN
- Austin, TX
- Dallas, TX
- Rutland, VT
- Abingdon, VA
- Richmond, VA
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