H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Phase: N/A
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Safety: Incidence of adverse events
Secondary outcome: Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)Incidence of asymptomatic LVEF decline Frequency of treatment discontinuations/interruptions
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
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
Casablanca 20502, Morocco
Casablanca 20052, Morocco
Casablanca 20100, Morocco
Casablanca, Morocco
Casablanca 20000, Morocco
Fes 30000, Morocco
Marrakech 40000, Morocco
Rabat, Morocco
Rabat 10000, Morocco
Rabat 21000, Morocco
Rabat 6213, Morocco
Additional Information
Starting date: November 2008
Last updated: November 18, 2013
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