Overview

This trial has been completed.

Condition breast cancer
Treatment trastuzumab [herceptin]
Sponsor Hoffmann-La Roche
Start date August 2007
End date May 2016
Trial size 3942 participants
Trial identifier NCT01152606, BO20652

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
trastuzumab [herceptin]
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.

Primary Outcomes

Measure
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

Measure
Time to onset and the time to recovery of symptomatic congestive heart failure
time frame: On treatment and up to 5 years follow-up
Incidence of asymptomatic cardiac failure and other significant cardiac conditions
time frame: On treatment and up to 5 years follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients who are considered candidates to receive Herceptin for this indication Exclusion Criteria: - Patients for whom Herceptin is contraindicated

Additional Information

Official title An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.