Clinical trial · Observational
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
NCT01991340CI-TRIAL-00012720completedClinicalTrials.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 observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Safety: Incidence of adverse events
- timeFrame
- up to approximately 4.5 years
Secondary outcomes (3)
- measure
- Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)
- timeFrame
- up to approximately 4.5 years
- measure
- Incidence of asymptomatic LVEF decline
- timeFrame
- up to approximately 4.5 years
- measure
- Frequency of treatment discontinuations/interruptions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.