H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
1 other identifier
observational
657
2 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedNovember 25, 2013
November 1, 2013
4.3 years
November 7, 2013
November 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
up to approximately 4.5 years
Secondary Outcomes (3)
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
Study Arms (1)
Cohort
Eligibility Criteria
Patients with HER2-positive breast cancer eligible for treatment with Herceptin
You may qualify if:
- Adult patients, \>/= 18 years of age
- Histologically confirmed HER2-positive breast cancer
- Eligible to receive Herceptin as per Summary of Product Characteristics
You may not qualify if:
- Contra-indications according to Summary of Product Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Algiers, 16000, Algeria
Unknown Facility
Annaba, 23000, Algeria
Unknown Facility
Blida, 9000, Algeria
Unknown Facility
Mascara, 29000, Algeria
Unknown Facility
Oran, 31000, Algeria
Unknown Facility
Sidi Belabes, 22000, Algeria
Unknown Facility
Tizi Ouzou, 15000, Algeria
Unknown Facility
Agadir, 80000, Morocco
Unknown Facility
Casablanca, 20000, Morocco
Unknown Facility
Casablanca, 20052, Morocco
Unknown Facility
Casablanca, 20100, Morocco
Unknown Facility
Casablanca, 20502, Morocco
Unknown Facility
Casablanca, Morocco
Unknown Facility
Fes, 30000, Morocco
Unknown Facility
Marrakesh, 40000, Morocco
Unknown Facility
Rabat, 10000, Morocco
Unknown Facility
Rabat, 21000, Morocco
Unknown Facility
Rabat, 6213, Morocco
Unknown Facility
Rabat, Morocco
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 25, 2013
Study Start
November 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 25, 2013
Record last verified: 2013-11