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

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: trastuzumab [Herceptin]

Study type: Observational

Funder types: Industry

Identifiers

NCT01152606

BO20652

Details and patient eligibility

About

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.

Enrollment: 3,942 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients for whom Herceptin is contraindicated

Trial design

3,942 participants in 1 patient group

Cohort

Treatment:

Drug: trastuzumab [Herceptin]