Breast Cancer
Conditions
Brief summary
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.
Interventions
There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who are considered candidates to receive Herceptin for this indication
Exclusion criteria
* Patients for whom Herceptin is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death | On treatment and up to 5 years follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset and the time to recovery of symptomatic congestive heart failure | On treatment and up to 5 years follow-up |
| Incidence of asymptomatic cardiac failure and other significant cardiac conditions | On treatment and up to 5 years follow-up |
Countries
Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed