UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002325 |
|---|---|
| Receipt number | R000002841 |
| Scientific Title | gene profiling study for the efficacy of Trastuzumab |
| Date of disclosure of the study information | 2009/08/11 |
| Last modified on | 2013/02/15 10:11:00 |
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Basic information
Public title
gene profiling study for the efficacy of Trastuzumab
Acronym
gene profiling study for the efficacy of Trastuzumab
Scientific Title
gene profiling study for the efficacy of Trastuzumab
Scientific Title:Acronym
gene profiling study for the efficacy of Trastuzumab
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
gene profiling
a. pretherapeutic
b. valiational
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
repeatability investigation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. stage IV or recurrence breast cancer patients
2. HER2 positive breast cancer patients with IHC or FISH
3. patients with hormone negative or with positive who were resistant to hormone therapy
4. patients with measurable region
5. PS0-2
6. patinets without visceral crisis
7. EF 55%<
8. patinets approved informed consent
Key exclusion criteria
1. patients with brain metastasis
2. patients with massive effusion
3. patinets with sever heart failure and reduced cardiac function caused treatment with trastuzumab
4. patients with pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujiwara |
Organization
National Cancer Center
Division name
breast and medical onoclogy division
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Shimizu |
Organization
National Cancer Center
Division name
breast and medical onoclogy
Zip code
Address
TEL
Homepage URL
NCC_IRBoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 11 | 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
Date of protocol fixation
| 2008 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | 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
prospective study
Management information
Registered date
| 2009 | Year | 08 | Month | 11 | Day |
Last modified on
| 2013 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002841
