H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01991340
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Histologically confirmed HER2-positive breast cancer
• Eligible to receive Herceptin as per Summary of Product Characteristics

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Exclusion Criteria

• Contra-indications according to Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to approximately 4.5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)	up to approximately 4.5 years
Incidence of asymptomatic LVEF decline	up to approximately 4.5 years
Frequency of treatment discontinuations/interruptions	up to approximately 4.5 years