A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients for whom Herceptin is contraindicated

Treatment and study plan

trastuzumab [Herceptin]

Drug

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

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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2016
Study completion: 2016
First posted: Jun 29, 2010
Registry last updated: Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed