UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006710 |
|---|---|
| Receipt number | R000007931 |
| Scientific Title | Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer |
| Date of disclosure of the study information | 2011/11/14 |
| Last modified on | 2013/11/11 12:58:03 |
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Basic information
Public title
Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer
Acronym
Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer
Scientific Title
Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer
Scientific Title:Acronym
Assessment on safety of intravenously administered trastuzumab with 100 ml saline solution in HER2 positive breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety of 30-minute intravenous infusion of trastuzumab with 100 ml saline solution in breast cancer patients with HER2 overexpression
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of infusion reaction after second treatment with trastuzumab
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 with 100 ml saline solution administered intravenously for 30 minutes
Inoperable metastatic breast cancer
Initial trastuzumab treatment: 4 mg/kg of trastuzumab with 250 ml saline solution administered intravenously for 90 minutes
Second trastuzumab treatment: 2 mg/kg of trastuzumab with 100 ml saline solution administered intravenously for 30 minutes
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key 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
Key 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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Abe |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
077-548-2238
abe@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Abe |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
077-548-2238
Homepage URL
abe@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2013 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007931
