Clinical trial · Observational
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)
Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations for the Treatment of Patients With HER2-Positive Early Breast Cancer (EBC)
NCT02658461CI-TRIAL-00021974completedResults postedClinicalTrials.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 prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study MO22982 (NCT01401166/PrefHer).
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 | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Trastuzumab IV Infusion
- description
- Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via IV infusion.
- interventionNames
- Drug: Trastuzumab
- label
- Trastuzumab SC Single-Use Injection Device
- description
- Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via SC single-use injection device.
- interventionNames
- Drug: Trastuzumab
- label
- Trastuzumab SC Vial/Syringe
- description
- Participants with HER2-positive EBC will be evaluated for the costs and other factors associated with health care utilization with the administration of trastuzumab via SC vial/syringe.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants from the MO22982 (PrefHer) clinical trial who consent to the presence of an observer to record data for the study during administration of trastuzumab * Members of the care team responsible for management of participants from the MO22982 (PrefHer) clinical trial who also consent to the presence of an observer during administration of trastuzumab Exclusion Criteria: * None specified
References
Publications (0)
Data not yet available
No reference posted for this study.