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Completed

NCT Number: NCT01991340

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

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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

  1. Safety: Incidence of adverse events

    Time frame: up to approximately 4.5 years

Secondary outcomes

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

    Time frame: up to approximately 4.5 years

  2. Incidence of asymptomatic LVEF decline

    Time frame: up to approximately 4.5 years

  3. Frequency of treatment discontinuations/interruptions

    Time frame: up to approximately 4.5 years

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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.

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