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)

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02658461

2010-024099-25 (EudraCT Number)

ML29123

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

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.

Treatment:

Drug: Trastuzumab

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.

Treatment:

Drug: Trastuzumab

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.

Treatment:

Drug: Trastuzumab