An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

Hoffmann-La Roche205 sites in 3 countries3,942 target enrollmentAugust 30, 2007

ConditionsBreast Cancer

Interventionstrastuzumab [Herceptin]

Drugstrastuzumab [Herceptin]

Overview

Phase: Not Applicable
Intervention: trastuzumab [Herceptin]
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 3942
Locations: 205
Primary Endpoint: Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 30, 2007

End Date

May 31, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients who are considered candidates to receive Herceptin for this indication

Exclusion Criteria

•Patients for whom Herceptin is contraindicated

Arms & Interventions

Cohort

Intervention: trastuzumab [Herceptin]

Outcomes

Primary Outcomes

Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death

Time Frame: On treatment and up to 5 years follow-up

Secondary Outcomes

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)