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)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658461
• Other study ID #: ML29123
• Secondary ID: 2010-024099-25
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 14, 2016
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: England: Medicines and Healthcare Regulatory Agency (MHRA)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total monetary cost of health care resources used per participant in the administration of trastuzumab via SC single-use injection device, estimated by consumable supplies and hourly salary data from National Health Service (NHS) reference costs		12 observations of an episode of care independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Total monetary cost of health care resources used per participant in the administration of trastuzumab via IV infusion, estimated by consumable supplies and hourly salary data from NHS reference costs		12 observations of an episode of care independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Total monetary cost of health care resources used per participant in the administration of trastuzumab via SC vial/syringe, estimated by consumable supplies and hourly salary data from NHS reference costs		12 observations of an episode of care independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Task-specific health care professional (HCP) time required per participant for administration of trastuzumab via each route/device, according to start and stop times for each observed task		12 observations of an episode of care per route/device independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Total HCP time required per participant for administration of trastuzumab via each route/device, according to start and stop times for all combined observed tasks		12 observations of an episode of care per route/device independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Number of medical supplies used per participant in the administration of trastuzumab via each route/device, according to count of consumable supplies recorded on the Case Report Form (CRF)		12 observations of an episode of care per route/device independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Total participant time spent in care unit for administration of trastuzumab via each route/device, according to arrival and departure time		12 observations of an episode of care per route/device independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No
Secondary	Total participant time spent in the chair for administration of trastuzumab via each route/device, according to start and stop 'chair' times		12 observations of an episode of care per route/device independent of the person being treated; data collection until the end of the MO22982 trial (up to 3 years)	No