Breast Cancer, Metastatic Breast Cancer
Conditions
Brief summary
This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.
Interventions
OTHERNo intervention
No intervention administered in this study
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression * Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) \> 50% * Good performance status: Eastern Cooperative Oncology Group (ECOG) scale \< or = 2 and life expectancy \> or = 12 weeks
Exclusion criteria
* Advanced pulmonary disease and severe dyspnea * Abnormal laboratory within 14 days prior to registration * Peripheral neuropathy \> grade 2 * Presence of central nervous system (CNS) metastasis * Pregnancy or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to 2 years |
| Percentage of Participants with Serious Adverse Events (SAEs) | Up to 2 years |
| Percentage of Deaths | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease | Up to 2 years |
Countries
Serbia
Outcome results
None listed