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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algiers, Algeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Nov 25, 2013
Registry last updated: Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed