UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005219 |
|---|---|
| Receipt number | 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 15:50:48 |
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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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006190
