Long-term safety of trastuzumab in patients with HER2-positive breast cancer

Long-term safety of trastuzumab in patients with HER2-positive breast cancer - Long-term safety of trastuzumab

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33506

Enrollment

100

Registered

2009-10-14

Start date

2009-10-22

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

decrease of left ventricular ejection fraction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Strongly HER2-positive breast cancer, defined as an immunohistochemistry score of 3+ using the HercepTestTM, or gene amplification by fluorescence in situ hybridization, or chromogenic in situ hybridization (CISH)

Exclusion criteria

Exclusion criteria: Pregnancy or breast feeding

Design outcomes

Secondary

Measure	Time frame
- NT-proBNP en troponin T analysis - New York Heart Association (NYHA) - genotype analysis - electrocardiogram	—

Primary

Measure	Time frame
- Left ventricular ejection fraction (LVEF)	—

Countries

Netherlands

Outcome results