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

JRCT ID: jRCT1041230177

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2 positive breast cancer
• Date of first enrollment: 28/03/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Use of a winged needle and a syringe pump

Outcome(s)

• Primary Outcome: Presense or absence of injection site reaction (Evaluated using CTCAE ver.5.0)
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shibata Takashi