Trial information
A Continuation Study of Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer
Status: Recruiting
Protocol number: BO15943
Sponsor: Hoffman-La Roche Ltd Global Development
Company division: Pharmaceutical
Official Scientific Title: A single arm, multi-centre, international, continuation trial of recombinant humanized antibody Herceptin® (trastuzumab) in patients with HER2 overexpressing tumors.
Brief summary: This study will evaluate the long-term safety of treatment with Herceptin in patients with metastatic breast cancer with HER2 overexpression who have completed a prior study with Herceptin. The anticipated time on study treatment is until Herceptin becomes commercially available or until disease progression , and the target sample size is <100 individuals.
Target sample size is 23.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Clinical outcome
Key secondary outcomes: 1. Safety: Serious adverse events
Inclusion criteria:
- female patients >=18 years of age;
- metastatic breast cancer;
- completed participation in a clinical trial of Herceptin;
- HER2 overexpression, as determined by the physician.
Exclusion criteria:
None stated
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 1999
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Brisbane
- Fitzroy
- Geelong
- Liverpool
- Parkville
- Waratah
Belgium
China
Germany
- Berlin
- Goettingen
- Hamburg
- Heidelberg
- Lübeck
- München
- Trier
Hungary
Israel
New Zealand
Panama
Poland
Portugal
Russian Federation
- Izhevsk
- Moscow
- St Petersburg
Spain
United Kingdom
- Edinburgh
- Glasgow
- London
- Nottingham
