Breast Cancer
Conditions
Interventions
Study Group:Patients were first treated with a handheld syringe subcutaneous injection. After completing 2 cycles, they will transfer to the micropump subcutaneous injection treatment group for contin
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-75 years old with histologically confirmed Her2-positive (IHC: 3+ or 2+ and FISH+) early-stage breast cancer 2. ECOG performance score of 0-1 and left ventricular ejection fraction =55% (echocardiogram score). 3. Radiotherapy or hormonal therapy is permitted. 4. Proposed use of pertuzumab trastuzumab regimen, including a portion of the concurrent or sequential regimen after neoadjuvant or adjuvant chemotherapy. 5. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding. 2. ECOG performance score >=2 points and BMI < 18.5kg/m^2. 3. Patients with advanced breast cancer who have been previously treated. 4. Echocardiogram LVEF <55%. 5. Severe heart disease/physical condition and impaired/insufficient organ/bone marrow function, unable to tolerate neoadjuvant/adjuvant therapy. 6. Broken or ulcerated skin on the thighs. 7. Known severe hypersensitivity to trastuzumab or/and pertuzumab. 8. Patients who are unwilling to comply with procedural requirements. 9. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. Patient is considered by the investigator to be unsuitable for any other condition to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' preference for subcutaneous injection with a handheld syringe or a micropump; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse reactions such as redness, swelling, and pain at injection site;Preference of medical staff; | — |
Countries
China
Contacts
Public ContactMingtao Shao
Jiangmen Central Hospital
Outcome results
None listed