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)

CompletedOBSERVATIONAL
Enrollment

36

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab

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.

Trial Locations (4)

BN2 5BE

Brighton

CF14 2TL

Cardiff

ME16 9QQ

Maidstone

NG5 1PB

Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02658461 - 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) | Biotech Hunter | Biotech Hunter