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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01991340
• Date of registration: 07/11/2013
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
• Scientific title: H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
• Date of first enrolment: November 2008
• Target sample size: 657
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01991340
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Algeria, Morocco

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Primary Outcome(s)

Safety: Incidence of adverse events [Time Frame: up to approximately 4.5 years]

Secondary Outcome(s)

Incidence of symptomatic congestive heart failure (NYHA class II, III and IV) [Time Frame: up to approximately 4.5 years]

Frequency of treatment discontinuations/interruptions [Time Frame: up to approximately 4.5 years]

Incidence of asymptomatic LVEF decline [Time Frame: up to approximately 4.5 years]

Secondary ID(s)

ML21975

Source(s) of Monetary Support

Please refer to primary and secondary sponsors