UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Title of the study (Brief title)	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	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
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	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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