UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Title of the study (Brief title)	Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate maximum tolerated dose to determine recommended dose of S-1 and Lapatinib in patients with HER-2 positive metastatic breast cancer. To evaluate the safety and pharmacokinetics of S-1 plus Lapatinib combination chemotherapy in patients with HER-2 positive metastatic breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To determinate maximum tolerated dose and recommended dose
Key secondary outcomes	Pharmacokinetics of TS-1, safety

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	Combination chemotherapy consists of TS-1 (65-80 mg/m2/day, day 1 through 14), Lapatinib (1250 mg/day, day 1 through 21). Cycles are repeated every 3 weeks.
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	75 years-old >=
Gender	Female
Key inclusion criteria	1) Histologically or cytologically confirmed breast cancer with metastatic disease 2) age: >=20 and <=75 3) Her2 positive 4) Performance Status: 0-1(ECOG) 5) sufficient function of important organs a) WBC: >=3,000/mm3 b) Neutrophyl: >=1,500/mm3 c) Platelet: >=100,000/mm3 d) Hemoglobin: >=9.0g/dl e) sT.bil: <= 1.5 times of the upper limit of normal range in each institute f) ALT, AST: <= 2.5 times of the upper limit of normal range in each institute g) Ccr: >=60 ml/min/body 6) left ventricular ejection fraction: normal range in institute 7) with ability of oral intake 8) written informed consent
Key exclusion criteria	1) with active double cancer 2) with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 3) possible infection associated with clinical symptoms such as fever 4) uncontrolled pleural effusion, pericardial effusion 5) pregnant or nursing women or women who like be pregnant 6) with pulmonary fibrosis or pneumonitis 7) with history of mental disorder or treating it at the moment 8) with history of severe allergy 9) with severe allergy to TS-1 and Lapatinib 10) patients receiving Flucytosine 11) doctor's decision not to be registered to this study
Target sample size	6

Research contact person
Name of lead principal investigator	Yutaka Tokuda
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara-shi, Kanagawa 259-1193
TEL	0463-93-1121
Email	tokuda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Yasuhiro Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara-shi, Kanagawa 259-1193
TEL	0463-93-1121
Homepage URL
Email	luke-szk@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
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	東海大学医学部（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 15 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date
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	2011 Year 01 Month 21 Day
Last modified on	2018 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005852