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)

NCT02658461 | Completed Results

• 2 other identifiers: ML291232010-024099-25
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device

  The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.

  Data collection up to 1 year

• Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection

  The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.

  Data collection up to 1 year

Secondary Outcomes (15)

• Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion

  Data collection up to 1 year

• Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device

  Data collection up to 1 year

• Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection

  Data collection up to 1 year

• Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion

  Data collection up to 1 year

• Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion

  Data collection up to 1 year

Study Arms (3)

Trastuzumab IV Infusion

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.

Drug: Trastuzumab

Trastuzumab SC Single-Use Injection Device

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.

Drug: Trastuzumab

Trastuzumab SC Vial/Syringe

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.

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

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.

Also known as: Herceptin

Trastuzumab IV Infusion; Trastuzumab SC Single-Use Injection Device; Trastuzumab SC Vial/Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult females with HER2-positive EBC who participated in the parent study MO22982 will be observed in this non-interventional study.

You may qualify if:

• 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

You may not qualify if:

• None specified

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Brighton, BN2 5BE, United Kingdom

Location

Unknown Facility

Cardiff, CF14 2TL, United Kingdom

Location

Unknown Facility

Maidstone, ME16 9QQ, United Kingdom

Location

Unknown Facility

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The focus of the observation in this study was the HCP rather than the person being treated, so number of observations is reported everywhere instead of number of participants. Number of participants was not collected.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 18, 2016
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 29, 2016
• Results First Posted: March 25, 2016

Record last verified: 2016-03

Locations

GB (4)