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

NCT ID: NCT01991340

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

657 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Algiers, , Algeria

Site Status

Annaba, , Algeria

Site Status

Blida, , Algeria

Site Status

Mascara, , Algeria

Site Status

Oran, , Algeria

Site Status

Sidi Belabes, , Algeria

Site Status

Tizi Ouzou, , Algeria

Site Status

Agadir, , Morocco

Site Status

Casablanca, , Morocco

Site Status

Casablanca, , Morocco

Site Status

Casablanca, , Morocco

Site Status

Casablanca, , Morocco

Site Status

Casablanca, , Morocco

Site Status

Fes, , Morocco

Site Status

Marrakesh, , Morocco

Site Status

Rabat, , Morocco

Site Status

Rabat, , Morocco

Site Status

Rabat, , Morocco

Site Status

Rabat, , Morocco

Site Status

Countries

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Algeria Morocco

Other Identifiers

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ML21975

Identifier Type: -

Identifier Source: org_study_id