Clinical trial · Observational
Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer
Safety of Herceptin in Metastatic Breast Cancer
NCT02424682CI-TRIAL-00024581completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER 2 positive metastatic breast cancer
- description
- HER 2 positive metastatic breast cancer treated with Herceptin as per registered indication, until disease progression.
- interventionNames
- Other: No intervention
Primary outcomes (3)
- measure
- Percentage of Participants with Adverse Events (AEs)
- timeFrame
- Up to 2 years
- measure
- Percentage of Participants with Serious Adverse Events (SAEs)
- timeFrame
- Up to 2 years
- measure
- Percentage of Deaths
- timeFrame
- Up to 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.