Breast cancer
Conditions
Interventions
Adjuvant chemotherapy Initial trastuzumab treatment: 8 mg/kg of trastuzumab with 250 ml saline solution administered intravenously for 90 minutes Second trastuzumab treatment: 6 mg/kg of trastuzumab
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Histologically diagnosed as invasive breast cancer (2) HER2 overexpression is confirmed with IHC or FISH (3) Tolerable to trastuzumab initial treatment with 250 ml saline solution administered intravenously for 90 minutes (4) Age ≥18 years (5) ECOG performance status: 0-1 (6) Baseline left ventricular ejection fraction ≥55% based on echocardiography or MUGA scan (7) Signed informed consent
Exclusion criteria
Exclusion criteria: (1) Inflammatory breast cancer (2) Serious underlying disease (3) Pregnant or lactating patients (4) Cumulative administration of previous treatment is > 360 mg/m2 of doxorubicin or > 720 mg/m2 of epirubicin (5) Ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infusion reaction after second treatment with trastuzumab | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events after second treatment with trastuzumab 2. Incidence of adverse events including infusion reaction at the time of initial treatment with trastuzumab 3. Impact on cardiac function (frequency/time of cardiac hypofunciton) | — |
Countries
Japan
Contacts
Public ContactHajime Abe
Shiga University of Medical Science Division of Breast and General Surgery
Outcome results
None listed