Trial information

A Study of Avastin (Bevacizumab) plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Status: Recruiting

Protocol number: MO19391

Sponsor: F. Hoffmann-La Roche Ltd

Company division: Pharmaceutical

Official Scientific Title: An open-label study to evaluate the safety and effect on disease progression and overall survival of Avastin plus taxane-based chemotherapy in patients with locally recurrent or metastatic breast cancer

Brief summary: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. Target sample size is 2300.

Study phase: III

Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study

Condition: Breast Cancer

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: 1. Incidence of AEs, and SAEs related to Avastin Time frame: Throughout study

Key secondary outcomes: 1. Duration of survival, time to disease progression Time frame: Event driven

Inclusion criteria:

• patients, >=18 years of age;
• HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
• candidates for chemotherapy.

Exclusion criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• concomitant hormonal therapy for metastatic or locally recurrent disease;
• concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
• previous radiotherapy for treatment of metastatic disease;
• evidence of CNS metastases.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: September, 2006

Trial registration date: 07/19/2006

Date last updated: 8/29/2008

Link to trial result

This trial is being conducted at the following locations:

Algeria

• Alger

Argentina

• Buenos Aires
• La Plata
• Mar Del Plata
• Rosario
• Tucuman

Australia

• Adelaide
• Brisbane
• Darlinghurst
• East Melbourne
• Frankston
• Lismore
• Maroochydore
• Perth
• Richmond
• St. Leonards
• Sydney
• Wodonga

Austria

• Bregenz
• Dornbirn
• Innsbruck
• Krems
• Leoben
• Linz
• St Pölten
• Wels
• Wien
• Wiener Neustadt

Brazil

• Belo Horizonte
• Campinas
• Curitiba
• Fortaleza
• Goiania
• Ijuí
• Jaú
• Niteroi
• Piracicaba
• Porto Alegre
• Ribeirão Preto
• Rio De Janeiro
• Salvador
• Sao Paulo
• Vitoria

Bulgaria

• Plovdiv
• Sofia
• Varna
• Veliko Tarnovo

Canada

• Surrey, BC
• Barrie, ON
• Brampton, ON
• Mississauga, ON
• Newmarket, ON
• Sault Ste Marie, ON
• Scarborough, ON
• St. Catharines, ON
• Toronto, ON
• Windsor, ON
• Montreal, QC
• Quebec City, QC
• Regina, SK

China

• Beijing
• Chang Sha
• Changchun
• Chengdu
• Chongqing
• Guangzhou
• Hang Zhou
• He Fei
• Hong Kong
• Nanjing
• Shanghai
• Suzhou
• Tianjin

Colombia

• Cali
• Neiva
• Pereira

Czech Republic

• Brno
• Hradec Kralove
• Ostrava
• Praha

Ecuador

• Quito

Egypt

• Alexandria

Estonia

• Tallinn
• Tartu

Finland

• Haemeenlinna
• Kotka
• Kuopio
• Pori
• Tampere
• Turku
• Vaasa

France

• Ales
• Angers
• Avignon
• Bayonne
• Besancon
• Bobigny
• Bordeaux
• Boulogne Sur Mer
• Boulogne-Billancourt
• Brest
• Chalon Sur Saone
• Chateauroux
• Chaussée Saint Victor
• Colmar
• Compiegne
• Creteil
• Dax
• Dijon
• Gap
• Grenoble
• Le Coudray
• Le Mans
• Libourne
• Lille
• L'Isle D'Espagnac
• Lyon
• Mantes La Jolie
• Marseille
• Metz
• Montbeliard
• Mont-De-Marsan
• Montfermeil
• Mougins
• Nancy
• Neuilly-Sur-Seine
• Nevers
• Nimes
• Niort
• Paris
• Perigueux
• Perpignan
• Pierre Benite
• Reims
• Rouen
• Saint Brieuc
• Saint Gregoire
• Saint Jean
• Saint Pierre
• Saint-Cloud
• Saint-Denis
• Saint-Priest-En-Jarez
• Strasbourg
• Toulon
• Toulouse
• Tours
• Valenciennes
• Vandoeuvre-Les-Nancy
• Vannes

Germany

• Augsburg
• Bad Saarow
• Berlin
• Bielefeld
• Böblingen
• Bochum
• Chemnitz
• Deggendorf
• Dresden
• Duisburg
• Erfurt
• Essen
• Freiburg
• Halle
• Hamburg
• Hannover
• Kassel
• Kiel
• Leipzig
• Lübeck
• Magdeburg
• Mainz
• München
• Regensburg
• Rostock
• Saarbrücken
• Stralsund
• Stuttgart
• Troisdorf
• Ulm
• Unna
• Wiesbaden
• Wuppertal
• Würselen

Hungary

• Budapest
• Szeged

Israel

• Ashkelon
• Beer Sheva
• Haifa
• Holon
• Jerusalem
• Kfar Saba
• Nahariya
• Petah Tikva
• Ramat Gan
• Rehovot
• Safed
• Tel Aviv
• Zerifin

Italy

• Ancona
• Aviano
• Brescia
• Cagliari
• Candiolo
• Carpi
• Castelfranco Veneto
• Castrovillari
• Catania
• Chieti
• Como
• Cremona
• Frattamaggiore
• Genova
• Lecce
• Lido Di Camaiore
• Lucca
• Mantova
• Messina
• Milano
• Montevarchi
• Napoli
• Novara
• Palermo
• Paola
• Pavia
• Piove Di Sacco
• Pordenone
• Pozzuoli
• Prato
• Ravenna
• Rionero in Vulture
• Roma
• Salerno
• San Giovanni Rotondo
• Saronno
• Sassari
• Siena
• Torino
• Verona
• Vicenza

Latvia

• Riga

Lebanon

• Beirut

Lithuania

• Kaunas
• Klaipeda
• Vilnius

Malaysia

• Kuala Lumpur

Mexico

• Chihuahua
• Ciudad Juarez
• Guadalajara
• Leon
• Mexico City
• Puebla
• Tijuana

Morocco

• Rabat

Netherlands

• Amsterdam
• Blaricum
• Capelle Ad Yssel
• Delftzijl
• Doetinchem
• Goes
• Hoofddorp
• Vlissingen
• Zoetermeer

Poland

• Bydgoszcz
• Lublin
• Olsztyn
• Poznan
• Warszawa

Portugal

• Almada
• Aveiro
• Barreiro
• Beja
• Cascais
• Coimbra
• Lisboa
• Porto
• Santarém
• Setubal
• Vila Nova De Gaia

Russian Federation

• Balashikha
• Barnaul
• Ekaterinburg
• Engels
• Irkutsk
• Izhevsk
• Kazan
• Kursk
• Moscow
• Smolensk
• St Petersburg
• Stavropol
• Tumen
• Tver
• Ufa
• Ulyanovsk

Saudi Arabia

• Jeddah
• Riyadh

Slovakia

• Banska Bystrica
• Bratislava
• Kosice
• Poprad
• Presov
• Zilina

Slovenia

• Ljubljana

Spain

• Alcorcon
• Barakaldo
• Barcelona
• Castellon
• Gijon
• Las Palmas de Gran Canaria
• Logroño
• Madrid
• Manresa
• Murcia
• Navarra
• Orense
• Palma de Mallorca
• Pontevedra
• Sabadell
• Sagunto
• Salamanca
• San Sebastian
• Santiago de Compostela
• Terrassa
• Valencia
• Vigo

Sweden

• Goeteborg
• Jonkoping
• Kalmar
• Karlstad
• Linkoeping
• Malmoe
• Stockholm
• Sundsvall
• Västerås
• Vaxjo

Switzerland

• Aarau
• Baden
• Locarno
• Lugano

Turkey

• Adana
• Ankara
• Gaziantep
• Istanbul
• Izmir

United Kingdom

• Colchester
• Coventry
• Dundee
• Glasgow
• London
• Peterborough
• Sutton
• Truro
• Westcliffe-on-Sea
• Worthing