Clinical trial · Observational
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
NCT02286362CI-TRIAL-00029675completedClinicalTrials.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 non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
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 (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure)
- timeFrame
- approximately 13 months
Secondary outcomes (3)
- measure
- Demographic data
- timeFrame
- Up to 12 months
- measure
- Number of modalities regarding dose and injection site of Herceptin SC administration
- timeFrame
- Up to 12 months
- measure
- Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged \>/= 18 years * Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment * Patients for whom the investigator has decided to start a treatment with Herceptin SC * Trastuzumab treatment naive or non-naive (previously intravenous treatment) * Informed consent Exclusion Criteria: * Patients previously treated with Herceptin SC treatment
References
Publications (0)
Data not yet available
No reference posted for this study.