UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004819 |
|---|---|
| Receipt number | R000005737 |
| Scientific Title | Phase II trial of trastumab and weekly paclitaxel for breast cancer. -Japan Breast Cancer Research Network (JBCRN) Trial |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2011/07/05 09:04:08 |
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Basic information
Public title
Phase II trial of trastumab and weekly paclitaxel for breast cancer.
-Japan Breast Cancer Research Network (JBCRN) Trial
Acronym
trastumab and weekly paclitaxel for breast cancer.
Scientific Title
Phase II trial of trastumab and weekly paclitaxel for breast cancer.
-Japan Breast Cancer Research Network (JBCRN) Trial
Scientific Title:Acronym
trastumab and weekly paclitaxel for breast cancer.
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy of abraxane and weekly paclitaxel combination therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response
Key secondary outcomes
safety
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
abraxane and paclitaxel
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patient should be daignose metastatic breast cancer
2 The metastatic size should be more than 10 mmm.
Key exclusion criteria
1) Patient had already treated with palitaxel or trastumab.
2) anaphyaxy of durg
3) pregnant condition
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | dago yamamoto |
Organization
kansai Medical University
Division name
surgery
Zip code
Address
2-3-1
TEL
02-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
kansai meical university
Division name
surgery
Zip code
Address
2-3-1 shinmachi, hirakata-city, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Japan Breast Cancer Research Network (JBCRN)
Institute
Department
Personal name
Funding Source
Organization
Japan Breast Cancer Research Network (JBCRN)
Organization
Division
Category of Funding Organization
Other
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
関西医科大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 04 | Day |
Last modified on
| 2011 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
