CloseHER2 Home: a community pharmacy-led pathway for the administration of trastuzumab for HER2-positive breast cancer patients

CloseHER2 Home: A feasibility study of a community pharmacy-led pathway for the administration of subcutaneous trastuzumab for HER2-positive breast cancer patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15965214

Enrollment

Registered

2022-06-09

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive breast cancer Cancer

Interventions

The intervention under study is a new model of care for the administration of subcutaneous trastuzumab via a community pharmacy-led pathway (CPP). Patients prescribed a course of subcutaneous trastuzu

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, =16 years of age 2. Able to provide informed consent 3. Prescribed a course of trastuzumab for the treatment of breast cancer 4. Tolerated at least one dose of subcutaneous trastuzumab administered by a chemotherapy nurse in the acute setting 5. Have a minimum of 4 cycles outstanding in the currently prescribed course

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent 2. History of severe allergic or immunological reactions 3. Less than 4 cycles outstanding in the prescribed course of trastuzumab

Design outcomes

Primary

Measure	Time frame
1. Proportion of consenting patients completing 4 cycles of trastuzumab via the Community Pharmacy Pathway (CPP), compared to the eligible cohort of patients (from Chemocare booking system) and also the eligible patients who consented over a period of one year OR maximum recruitment of 50 patients is reached measured at the end of the study using patient records 2. Process evaluation of CPP by qualitative methods including semi-structured interviews with participants receiving the intervention and standard care and staff delivering the intervention and staff delivering standard care measured using interviews at the end of each individual's intervention period	—

Measure

Time frame

1. Proportion of consenting patients completing 4 cycles of trastuzumab via the Community Pharmacy Pathway (CPP), compared to the eligible cohort of patients (from Chemocare booking system) and also the eligible patients who consented over a period of one year OR maximum recruitment of 50 patients is reached measured at the end of the study using patient records 2. Process evaluation of CPP by qualitative methods including semi-structured interviews with participants receiving the intervention and standard care and staff delivering the intervention and staff delivering standard care measured using interviews at the end of each individual's intervention period

—

Secondary

Measure	Time frame
1. Assess compliance with professional and legal standards set out in the Scottish SACT governance framework audit tool using a patient and staff evaluation via semi-structured interviews at the end of the study 2. Evaluate the practicality of the CPP using patient and staff evaluation via semi-structured interviews at the end of the study 3. Economic assessment of the CPP and the conventional care pathway using NHS Reference costs to model both pathways at the end of the study	—

Measure

Time frame

1. Assess compliance with professional and legal standards set out in the Scottish SACT governance framework audit tool using a patient and staff evaluation via semi-structured interviews at the end of the study 2. Evaluate the practicality of the CPP using patient and staff evaluation via semi-structured interviews at the end of the study 3. Economic assessment of the CPP and the conventional care pathway using NHS Reference costs to model both pathways at the end of the study

—

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026