UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006464 |
|---|---|
| Receipt number | R000007668 |
| Scientific Title | A translational study of "Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes." |
| Date of disclosure of the study information | 2011/10/04 |
| Last modified on | 2018/09/18 16:03:56 |
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Basic information
Public title
A translational study of "Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes."
Acronym
A biomarker study of WJOG6110B: Early switch to Lapatinib versus Trastuzumab beyond Progression (ELTOP) study
Scientific Title
A translational study of "Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes."
Scientific Title:Acronym
A biomarker study of WJOG6110B: Early switch to Lapatinib versus Trastuzumab beyond Progression (ELTOP) study
Region
| Japan |
Condition
Condition
HER2-positive metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Searching a biomarker for progression-free survival, response rate and survival time of trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Searching a biomarker for progression-free survival, response rate and survival time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
trastuzumab + capecitabine
Interventions/Control_2
lapatinib + capecitabine
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
Patients who were enrolled in the study of "Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes."Signed written informed consent
Key exclusion criteria
None
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Nishio |
Organization
Kinki University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka, 589-8511, JAPAN
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
Datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization
Profit 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
| 2011 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29698927
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 | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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 | 10 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007668
| 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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| Registered date | File name |
