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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991340
• Other study ID #: ML21975
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 18, 2013
• Start date: November 2008
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: unknown: unknown
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Algeria,  Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		up to approximately 4.5 years	No
Secondary	Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)		up to approximately 4.5 years	No
Secondary	Incidence of asymptomatic LVEF decline		up to approximately 4.5 years	No
Secondary	Frequency of treatment discontinuations/interruptions		up to approximately 4.5 years	No