Clinical trial · Observational
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
NCT01152606CI-TRIAL-00031373completedClinicalTrials.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 is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab [Herceptin] | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- interventionNames
- Drug: trastuzumab [Herceptin]
Primary outcomes (1)
- measure
- Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death
- timeFrame
- On treatment and up to 5 years follow-up
Secondary outcomes (2)
- measure
- Time to onset and the time to recovery of symptomatic congestive heart failure
- timeFrame
- On treatment and up to 5 years follow-up
- measure
- Incidence of asymptomatic cardiac failure and other significant cardiac conditions
- timeFrame
- On treatment and up to 5 years follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who are considered candidates to receive Herceptin for this indication Exclusion Criteria: * Patients for whom Herceptin is contraindicated
References
Publications (0)
Data not yet available
No reference posted for this study.