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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002456
Receipt No. R000003008
Scientific Title Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Date of disclosure of the study information 2009/09/07
Last modified on 2017/11/30

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Basic information
Public title Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Acronym Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Scientific Title Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Scientific Title:Acronym Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Endocrine surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Clinical benefit rate
Key secondary outcomes Safety
Overall response rate
Progression free survival
Time to treatment failure
Biomarkers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lapatinib at a dose of 1250 mg daily.
Capecitabine at a dose of 2000 mg per square meter of body-surface area in two divided doses on days 1 through 14 of a 21-day cycle.
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
80 years-old >=
Gender Female
Key inclusion criteria 1) Histologically diagnosed breast cancer
2) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site
3) Patients who received previous treatment with oral FU agents
4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant
5) Case who passes from the final administering of FU agents one month when FU agents is dministered by pre-treatment
6) Case to whom metastasis to central nervous system is steady
7) ECOG PS 0 to 2
8) Possible to take orally
9) Required baseline laboratory parameters within 14 days before it registers
AST <= 3.0 times ULN and ALT <= 3.0 times ULN
Case where abnormal shadow is not admitted by chest image inspection (X rays of chest or CT)
LVEF<=ULN(LVEF more than 50%)
Ccr >= 50ml/min (Cockcroft-Gault model)
Neu >= 1,500 / mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
10) Age>=20
11) Written informed consent
Key exclusion criteria 1) Concomitant infectious disease
2) History of lung disease, pulmonary fibrosis
3) Uncontrollable complication heart disease
4) have hypersensitivity to lapatinib and capecitabine
5) During pregnancy or lactation
6) History of serious hypersensitivity to fluoropyrimidines
7) Patients who received previous treatment with oral fluoropyrimidines within 12 months
8)The patient who has the risk of the extension at QT intervals is a case who assumes that it consults the specialist, and the treatment of the examination is inapposite.
9) Present case to whom radiation therapy is enforced
10) Doctors decision for excluion
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Breast Medical Oncology
Zip code
Address 818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan
TEL 048-722-1111
Email ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name Secretariat Division (Shintoshin Ladies' MammoClinic)
Zip code
Address 3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL 048-600-1722
Homepage URL http://www.sbccsg.org/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 09 Month 07 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 Completed
Date of protocol fixation
2009 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2016 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 06 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003008

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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