UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002660 |
|---|---|
| Receipt number | R000003236 |
| Scientific Title | A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells |
| Date of disclosure of the study information | 2009/10/22 |
| Last modified on | 2013/04/12 11:46:47 |
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Basic information
Public title
A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells
Acronym
A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells
Scientific Title
A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells
Scientific Title:Acronym
A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells
Region
| Japan |
Condition
Condition
bresat cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of biomarker predictive of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate after enrichment by gene signature
Key secondary outcomes
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
single-agent trastuzumab
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. histologically confirmed HER2-positive breast cancer patients
2. Stage IV or recurrent breast cancer
3. hormone-receptor negative or hormone-refractory
4. non life-threatning disease
5. at least one measurable lesion
6. ejection fraction no less than 55%
7. written consent by the patient
Key exclusion criteria
1. uncontrolled CNS metastasis
2. co-existence of heart failure or past history of decline in cardiac function during trastuzumab treatment
3. pregnant women
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujiwara |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center
Division name
Breast and Medical Oncology Division
Zip code
Address
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
Chikako Shimizu, Kenji Tamura
Institute
Department
Personal name
Funding Source
Organization
New Enrgy and Industrial Techology Develoment Organization Grant
Organization
Division
Category of Funding Organization
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
国立がんセンター中央病院、聖路加国際病院、国立病院機構四国がんセンター
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 22 | Day |
Last modified on
| 2013 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003236
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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