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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

Page last updated: August 23, 2015

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