Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer
Not Applicable
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000006710
- Lead Sponsor
- Shiga University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of infusion reaction after second treatment with trastuzumab
- Secondary Outcome Measures
Name Time Method 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)