Safety investigation of a winged needle and a syringe pump for PHESGO administration.

Safety investigation of administration method using a winged needle and a syringe pump for PHESGO Combination for Subcutaneous Injection.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041230177

Enrollment

Registered

2024-03-28

Start date

2024-03-28

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

HER2 positive breast cancer

Interventions

Use of a winged needle and a syringe pump

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) HER2 positive breast cancer (2) Patients scheduled to receive chemotherapy containing pertuzumab and trastuzumab (3) Ejection fraction 55% or more on cardiac ultrasound examination

Exclusion criteria

Exclusion criteria: (1) Patients who do not wish to receive subcutaneous administration (2) Subcutaneous administration to the thigh is difficult (ex. lack of subcutaneous tissue, presense of lower limb edema) (3) Patients with markedly decreased heart function (4) Patients who do not wish to participate in this study

Design outcomes

Primary

Measure	Time frame
Presense or absence of injection site reaction (Evaluated using CTCAE ver.5.0)	—

Contacts

Public ContactTakashi Shibata

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

shiba48ten@nagoya2.jrc.or.jp+81-52-832-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026