UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004921
Receipt No. R000005852
Scientific Title Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Date of disclosure of the study information 2011/01/21
Last modified on 2018/02/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Acronym Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Scientific Title Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Yutaka Tokuda
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
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
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
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)

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 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

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
2010 Year 11 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.