UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002456 |
|---|---|
| Receipt number | 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 18:04:58 |
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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
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/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003008
