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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: trastuzumab [Herceptin]

• Registration Number: NCT01152606
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3942

Inclusion Criteria

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

Exclusion Criteria

• Patients for whom Herceptin is contraindicated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	trastuzumab [Herceptin]	-

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death	On treatment and up to 5 years follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (205)

Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie; 🇦🇹 Graz, Austria

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

Lhk Klagenfurt; Abt. Für Gynäkologie; 🇦🇹 Klagenfurt, Austria

LKH Hochsteiermark; Abt. für Innere Medizin; 🇦🇹 Leoben, Austria

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1; 🇦🇹 Linz, Austria

Lhk Feldkirch; Interne Medizin Abt.; 🇦🇹 Rankweil, Austria

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.; 🇦🇹 Salzburg, Austria

A. Ö. Krankenhaus Der Barmherzigen Brüder; Abt. Für Chirurgie; 🇦🇹 St Veit An Der Glan, Austria

A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie; 🇦🇹 Steyr, Austria

Lhk Vöcklabruck; Ii. Interne Abt.; 🇦🇹 Vöcklabruck, Austria

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