Trial information

A Study to Evaluate the Efficacy and Safety of Herceptin (Trastuzumab) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer

Status: No longer recruiting

Protocol number: BO16216

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Herceptin plus Arimidex compared with Arimidex alone on progression-free survival in patients with HER2-positive and hormone-receptor positive metastatic breast cancer

Brief summary: This 2 arm study will assess the safety and efficacy of adding intravenous Herceptin to daily oral anastrozole (Arimidex) tablets as first- and second-line treatment in postmenopausal patients with HER2 overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients will be randomized to receive either anastrazole 1mg po daily,or anastrazole 1mg po daily + a loading dose of Herceptin 4mg/kg iv followed by weekly doses of Herceptin 2mg/kg iv. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 202.

Study phase: III

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

Condition: Breast Cancer

Intervention type: Drug

Intervention name: trastuzumab [Herceptin]

Primary outcome: 1. Tumor measurements Time frame: Event driven

Key secondary outcomes: 1. Hematology, serum chemistry, clinical safety assessments, cardiac monitoring. Time frame: Throughout study

Inclusion criteria:

• postmenopausal women;
• metastatic breast cancer suitable for endocrine therapy;
• positive hormone receptor status;
• HER2 overexpression.

Exclusion criteria:

• patients on hormone replacement therapy;
• previous chemotherapy for metastatic disease;
• uncontrolled cardiac disease and history of cardiac failure.

Gender: Females

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

Accepts healthy volunteers: No

Anticipated start date: January, 2001

Trial registration date: 06/24/2005

Date last updated: 10/15/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Waratah

Brazil

• Porto Alegre

Bulgaria

• Plovdiv
• Sofia
• Stara Zagora

Canada

• Calgary, AB
• Edmonton, AB
• Toronto, ON
• Quebec City, QC

China

• Beijing
• Hong Kong
• Shanghai
• Wuhan

France

• Avignon
• Nice

Germany

• Frankfurt Am Main
• Kiel
• München
• Trier

Hungary

• Budapest

India

• Ahmedabad
• Bangalore
• Chennai
• Cuttack
• Ludhiana
• Mumbai
• New Delhi

Israel

• Haifa
• Petah Tikva
• Ramat Gan
• Rehovot
• Tel Aviv

Lithuania

• Vilnius

Mexico

• Guadalajara
• Mexico City

Netherlands

• Amsterdam
• Rotterdam

Norway

• Trondheim

Poland

• Bialystok
• Bydgoszcz
• Gliwice
• Krakow
• Lodz
• Szczecin
• Warszawa

Russian Federation

• Barnaul
• Izhevsk
• Kazan
• Krasnodar
• Moscow
• St Petersburg

South Africa

• Floracliffe
• Pretoria

Spain

• Barcelona
• Córdoba
• Girona
• Madrid
• Mataro
• Reus
• Valencia

Sweden

• Boras
• Gaevle
• Oerebro
• Stockholm

Taiwan

• Taipei
• Taoyuan

Turkey

• Ankara
• Istanbul
• Izmir

Ukraine

• Kiev
• Lvov
• Odessa
• Sumy
• Zaporozhye

United Kingdom

• Cardiff
• Guildford
• Ipswich
• London
• Manchester
• Merseyside
• Newcastle upon Tyne
• Southampton
• Swansea

United States

• Little Rock, AR
• Vallejo, CA
• Plantation, FL
• Scarborough, ME
• Detroit, MI
• Rochester, NY
• Cincinnati, OH
• Cleveland, OH