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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006464
Receipt No. 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

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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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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