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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01152606
• Date of registration: 28/06/2010
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
• Scientific title: An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
• Date of first enrolment: August 2007
• Target sample size: 3942
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01152606
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Patients for whom Herceptin is contraindicated



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: trastuzumab [Herceptin]

Primary Outcome(s)

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 Outcome(s)

Incidence of asymptomatic cardiac failure and other significant cardiac conditions [Time Frame: On treatment and up to 5 years follow-up]

Time to onset and the time to recovery of symptomatic congestive heart failure [Time Frame: On treatment and up to 5 years follow-up]

Secondary ID(s)

BO20652

Source(s) of Monetary Support

Please refer to primary and secondary sponsors