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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01991340

Enrollment

657

Registered

2013-11-25

Start date

2008-11-30

Completion date

2013-02-28

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Algeria, Morocco

Outcome results