Trial information

HERA study - A Study of Intravenous Herceptin (Trastuzumab) in Women With HER2-Positive Primary Breast Cancer

Status: No longer recruiting

Protocol number: BO16348

Sponsor: F Hoffman-La Roche Ltd

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Herceptin on disease-free and overall survival in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy

Brief summary: This study will compare the efficacy and safety of different treatment durations of intravenous Herceptin compared to observation (no treatment) in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 4482.

Study phase: III

Study type: Interventional; Treatment; Randomized; Open Label; Placebo; Parallel; Safety/Efficacy study

Condition: Breast Cancer

Intervention type: Drug

Intervention name: trastuzumab[Herceptin]

Primary outcome: 1. Disease-free survival

Key secondary outcomes: 1. Efficacy: Overall survival, relapse-free survival, distant disease-free survival. Safety: Adverse events, with special emphasis on cardiac safety, laboratory parameters.

Inclusion criteria:

• female patients, >=18 years of age, with HER2-positive primary breast cancer;
• completion of adjuvant systemic chemotherapy and radiotherapy, if applicable.

Exclusion criteria:

• history of prior invasive breast cancer;
• prior use of any anti-HER2 therapy.

Gender: Females

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

Accepts healthy volunteers: No

Anticipated start date: December, 2001

Trial registration date: 06/24/2005

Date last updated: 8/19/2008

Link to trial result

This trial was conducted at the following locations:

Argentina

• Buenos Aires

Australia

• Adelaide
• Fitzroy
• Frankston
• Geelong
• Heidelberg
• Liverpool
• Melbourne
• Parkville
• Perth
• Sydney
• Toowoomba
• Waratah
• Wodonga

Austria

• Bludesch
• Graz
• Innsbruck
• Klagenfurt
• Linz
• Salzburg
• St Veit an der Glan
• Villach
• Vöcklabruck
• Wels
• Wien
• Wiener Neustadt

Belgium

• Antwerpen
• Baudour
• Bruxelles
• Charleroi
• Kortrijk
• Leuven
• Liege
• Namur
• Oostende
• Verviers

Brazil

• Porto Alegre
• Rio De Janeiro
• Santo Andre

Canada

• Calgary, AB
• Kelowna, BC
• Surrey, BC
• Vancouver, BC
• Victoria, BC
• Winnipeg, MB
• Mississauga, ON
• Sault Ste Marie, ON
• St. Catharines, ON
• Toronto, ON
• Windsor, ON
• Charlottetown, PE
• Quebec City, QC
• Regina, SK
• Saskatoon, SK

Chile

• Santiago

China

• Beijing
• Guangzhou
• Hangzhou
• Hong Kong
• Shanghai
• Wuhan

Costa Rica

• San José

Croatia

• Split
• Zagreb

Denmark

• Aalborg
• Esbjerg
• Herlev
• Herning
• Hillerød
• København
• Naestved
• Odense
• Roskilde
• Sønderborg
• Vejle
• Viborg

France

• Caen
• Limoges
• Metz

Germany

• Augsburg
• Bad Saarow
• Bayreuth
• Berlin
• Bonn
• Bremen
• Celle
• Chemnitz
• Dortmund
• Dresden
• Duisburg
• Düsseldorf
• Erlangen
• Essen
• Esslingen
• Frankfurt Am Main
• Freiburg
• Fulda
• Georgsmarienhütte
• Göttingen
• Greifswald
• Halle
• Hamburg
• Hameln
• Hamm
• Hannover
• Heidelberg
• Herne
• Ibbenbueren
• Jena
• Kaiserslautern
• Karlsruhe
• Kassel
• Kiel
• Köln
• Krefeld
• Kronach
• Lemgo
• Leonberg
• Leverkusen
• Lübeck
• Mannheim
• Minden
• München
• Münster
• Oberhausen
• Oldenburg
• Potsdam
• Quedlinburg
• Rheinfelden
• Rostock
• Rotenburg-Wuemme
• Rottweil
• Saarbrücken
• Stuttgart
• Trier
• Tübingen
• Ulm
• Wiesbaden
• Witten
• Würzburg

Greece

• Heraklion

Guatemala

• Guatemala City

Hungary

• Budapest
• Kecskemet
• Szeged

Ireland

• Cork

Israel

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

Italy

• Alba
• Ancona
• Arezzo
• Aviano
• Bergamo
• Biella
• Bologna
• Bolzano
• Brescia
• Cagliari
• Camposampiero
• Carpi
• Casalpusterlengo
• Castelfranco Veneto
• Como
• Cosenza
• Cuneo
• Fano
• Firenze
• Genova
• Lecco
• Legnano
• Livorno
• Lucca
• Mantova
• Milano
• Modena
• Napoli
• Noale
• Padova
• Palermo
• Parma
• Pavia
• Perugia
• Pisa
• Ragusa
• Reggio Emilia
• Rionero in Vulture
• Roma
• Rozzano
• San Giovanni Rotondo
• Sassari
• Segrate
• Siena
• Thiene
• Torino
• Trento
• Trieste
• Udine
• Varese
• Vecchiazzano
• Venezia
• Vicenza

Japan

• Aichi
• Chiba
• Kanagawa
• Matsuyama-Shi, Ehime
• Tochigi
• Tokyo

Korea, Republic of

• Seoul

Mexico

• Chihuahua
• Guadalajara
• Merida
• Mexicali
• Mexico City
• Monterrey
• Obregon

Netherlands

• Amsterdam
• Leiden
• Maastricht
• Rotterdam
• Sittard
• Utrecht

New Zealand

• Auckland
• Christchurch
• Dunedin
• Palmerston North
• Wellington

Norway

• Oslo
• Tromsø

Panama

• Panama City

Poland

• Gdansk
• Gliwice
• Krakow
• Lodz
• Poznan
• Warszawa

Portugal

• Coimbra
• Faro
• Lisboa
• Porto
• Setubal

Russian Federation

• Barnaul
• Kazan
• Moscow
• St Petersburg

Singapore

• Singapore

Slovakia

• Banska Bystrica
• Bratislava
• Zilina

South Africa

• Cape Town
• Durban
• Johannesburg
• Lynnwood
• Sandton

Spain

• Alzira
• Barcelona
• Caceres
• Cádiz
• Guadalajara
• Huelva
• Jaen
• La Coruna
• La Laguna
• Las Palmas de Gran Canaria
• Lleida
• Madrid
• Malaga
• Mataro
• Navarra
• Orense
• Oviedo
• Palma de Mallorca
• Pontevedra
• Sabadell
• Santa Cruz de Tenerife
• Sevilla
• Terrassa
• Toledo
• Valencia
• Vigo
• Zaragoza

Sweden

• Gaevle
• Linkoeping
• Lund
• Malmoe
• Molndal
• Stockholm
• Umea
• Uppsala
• Västerås

Switzerland

• Aarau
• Basel
• Bern
• Chur
• Lausanne
• Mendrisio
• St Gallen
• Zürich

Taiwan

• Changhua
• Kaohsiung
• Taichung
• Tainan
• Taipei
• Taoyuan

Thailand

• Bangkok

United Kingdom

• Aberdeen
• Belfast
• Birmingham
• Blackpool
• Bournemouth
• Brighton
• Bristol
• Cambridge
• Cardiff
• Chelsmford
• Cheltenham
• Colchester
• Dundee
• East Kilbride
• Edinburgh
• Epping
• Exeter
• Glasgow
• Huddersfield
• Hull
• Ipswich
• Kilmarnock
• Kings Lynn
• Lancaster
• Leeds
• London
• Manchester
• Merseyside
• Middlesborough
• Middlesex
• Newcastle upon Tyne
• Oxford
• Peterborough
• Portsmouth
• Preston
• Romford
• Salisbury
• Scunthorpe
• Sheffield
• Shrewsbury
• Southampton
• Stoke-on-Trent
• Sutton
• Swansea
• Torquay
• Westcliffe-on-Sea
• Wolverhampton
• Worthing
• Yeovil
• York