CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Trastuzumabdrug
Likely dose
Trastuzumab 600 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02658461
NCT02658461N/ACompleted
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Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations for the Treatment of Patients With HER2-Positive Early Breast Cancer (EBC)

Hoffmann-La Roche·observational·Posted Jan 18, 2016·Updated Apr 29, 2016

In Brief

An observational study evaluating Trastuzumab for Breast Cancer. Completed, enrolled 36 participants across 4 sites.

Detailed Summary

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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2016
Enrollment StartFeb 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.5 years ago

Interventions

Trastuzumabdrug

Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed \>1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.