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

November 18, 2013 updated by: Hoffmann-La Roche

H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

657

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
      • Annaba, Algeria, 23000
      • Blida, Algeria, 9000
      • Mascara, Algeria, 29000
      • Oran, Algeria, 31000
      • Sidi Belabes, Algeria, 22000
      • Tizi Ouzou, Algeria, 15000
  • Morocco
      • Agadir, Morocco, 80000
      • Casablanca, Morocco, 20100
      • Casablanca, Morocco
      • Casablanca, Morocco, 20000
      • Casablanca, Morocco, 20502
      • Casablanca, Morocco, 20052
      • Fes, Morocco, 30000
      • Marrakech, Morocco, 40000
      • Rabat, Morocco, 21000
      • Rabat, Morocco, 10000
      • Rabat, Morocco, 6213
      • Rabat, Morocco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with HER2-positive breast cancer eligible for treatment with Herceptin

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: up to approximately 4.5 years
up to approximately 4.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)
Time Frame: up to approximately 4.5 years
up to approximately 4.5 years
Incidence of asymptomatic LVEF decline
Time Frame: up to approximately 4.5 years
up to approximately 4.5 years
Frequency of treatment discontinuations/interruptions
Time Frame: up to approximately 4.5 years
up to approximately 4.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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