H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
Sponsor study identifier
observational
657
2 countries
19
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)February 2013
Actual (reported)November 7, 2013
Actual (reported)November 25, 2013
Actual (reported)Safety: Incidence of adverse events
up to approximately 4.5 years
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
Patients with HER2-positive breast cancer eligible for treatment with Herceptin
Algiers, 16000, Algeria
Annaba, 23000, Algeria
Blida, 9000, Algeria
Mascara, 29000, Algeria
Oran, 31000, Algeria
Sidi Belabes, 22000, Algeria
Tizi Ouzou, 15000, Algeria
Agadir, 80000, Morocco
Clinical Trials
Hoffmann-La Roche
657 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2013
First Posted
November 25, 2013
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Casablanca, 20000, Morocco
Casablanca, 20052, Morocco
Casablanca, 20100, Morocco
Casablanca, 20502, Morocco
Casablanca, Morocco
Fes, 30000, Morocco
Marrakesh, 40000, Morocco
Rabat, 10000, Morocco
Rabat, 21000, Morocco
Rabat, 6213, Morocco
Rabat, Morocco
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
November 25, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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