UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010797 |
|---|---|
| Receipt number | R000012640 |
| Scientific Title | Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer |
| Date of disclosure of the study information | 2013/05/24 |
| Last modified on | 2019/09/24 00:22:26 |
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Basic information
Public title
Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer
Acronym
Predictive markers for anti-HER2 drugs
Scientific Title
Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer
Scientific Title:Acronym
Predictive markers for anti-HER2 drugs
Region
| Japan |
Condition
Condition
HER2 positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the mechanism of drug resistance to ant-HER2 drugs, leading to the improvement of clinical outcome for patients with HER2 positive breast cancer
Basic objectives2
Others
Basic objectives -Others
To correlate the presence of somatic gene mutations in cancer cells and drug efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To correlate the presence of somatic mutations in cancer cells and drug efficacy
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
Female
Key inclusion criteria
1.histologically diagnosed with invasive breast cancer,2.20 year or older, 3.IHC 3+ or HER2/CEP17>2.0 via FISH, 4. treated with lapatinib or trastuzumab, 5. archival tumor tissues available
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama Medical University International Medical Center
Division name
Surgery department
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University Faculty of Medicine
Division name
Medical Oncology department
Zip code
Address
TEL
072-366-0221
Homepage URL
Sponsor or person
Institute
Ministry of Education, Culture Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
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
| 2013 | Year | 05 | Month | 24 | 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
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preliminary results
Management information
Registered date
| 2013 | Year | 05 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012640
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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