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

N/ACompletedNCT01991340

Hoffmann-La Roche657 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

657

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically confirmed HER2-positive breast cancer * Eligible to receive Herceptin as per Summary of Product Characteristics Exclusion Criteria: * Contra-indications according to Summary of Product Characteristics

Locations (19)

Unnamed facility

Algiers, Algeria

Unnamed facility

Annaba, Algeria

Unnamed facility

Blida, Algeria

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time frame: up to approximately 4.5 years

Secondary Outcomes

Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)

Time frame: up to approximately 4.5 years

Incidence of asymptomatic LVEF decline

Time frame: up to approximately 4.5 years

Frequency of treatment discontinuations/interruptions

Time frame: up to approximately 4.5 years

Data from ClinicalTrials.gov

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