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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005219
Receipt No. R000006190
Scientific Title 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 2011/03/08
Last modified on 2018/09/18

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Basic information
Public title 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 WJOG6110B: Early switch to Lapatinib versus Trastuzumab beyond Progression (ELTOP) study
Scientific Title 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 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 NO

Objectives
Narrative objectives1 Evaluating efficacy and safety of trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall response rate, overall survival, proportion of subjects progressing with brain metastases as site of first progression, and safety

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 1) Pathologically confirmed invasive breast cancer
2) ECOG performance status 0-2
3) Metastatic breast cancer or unresectable locally advanced (stage IIIB/IIIC) breast cancer
4) HER2 positive (3+ staining by immunohistochemistry [IHC] or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed in the invasive component of the primary or metastatic lesion
5) Previously treated with taxanes
6) Disease progression or distant relapse has been observed during treatment with trastuzumab-containing regimens.
7) Previously untreated with oral fluoropyrimidines including capecitabine and S-1 (Eligible if oral fluoropyrimidines other than capecitabine and S-1 are used only in neo-adjuvant or adjuvant setting)
8) Previously untreated with HER2 tyrosine kinase inhibitors
9) Previously treated with no more than two chemotherapy regimens for metastatic or unresectable locally advanced disease
10) No brain metastases or asymptomatic brain metastases
11) Subjects who have either measurable or non-measurable disease other than brain metastases
12) Able to swallow oral medications
13) Adequate baseline organ and marrow function as defined below:
Absolute neutrophil count >=1.5x10^9/L
Hemoglobin >=9.0 g/dL
Platelets >=100x10^9/L
AST and ALT <=100IU/L
Serum bilirubin <=1.5 mg/dL
Serum creatinine <=1.5 mg/dL
14) Baseline LVEF >= 50% by echocardiography
15) Life expectancy of at least 3 months
16) Signed written informed consent
Key exclusion criteria 1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.)
2) Active infection under treatment
3) Concurrent serious disease or condition
4) Pulmonary fibrosis or interstitial pneumonitis by chest x-ray
5) Symptomatic brain metastases or carcinomatous meningitis
6) History of serious allergic reactions
7) Concurrent continuous systemic treatment with medications listed below:
Steroids
Warfarin
CYP3A4 inducing anticonvulsants
Rifampicin
Azole antifungals
8) Concurrent serious psychiatric disorder
9) Pregnant or lactating females or subjects of childbearing potential who do not agree to use adequate contraception
10) HBsAg-positive
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimi Takano
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL 03-3588-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
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 03 Month 08 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 02 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 05 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 03 Month 08 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=R000006190

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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