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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008647
Receipt No. R000010159
Scientific Title Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Date of disclosure of the study information 2012/08/08
Last modified on 2019/01/08

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Basic information
Public title Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Acronym Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Scientific Title Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Scientific Title:Acronym Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival(PFS)
Key secondary outcomes

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 TS-1 (80 mg/m2/day) is administered orally on days 3-7, 10-15 and 17-21. CPT-11 (60mg/m2) is injected by vein on day1, 8 and 15. Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for subsequent administration, day1, 8, 15, 22
Cycles are repeated every 4 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
80 years-old >=
Gender Female
Key inclusion criteria 1.Histological and/or cytological confirmed breast cancer
2.Metastatic breast cancer
3.HER2 positive (3+ staining by IHC or HER2 gene amplification by FISH) confirmed in the invasive component of the primary or metastatic lesion
4.age: >=20 and <80
5.Performance Status: 0-2 (ECOG)
6.The below criteria are met about prior therapy
(1)chemotherapy: more than 7 days passed after chemotherapy
(2)hormonal therapy: more than 7 days passed after hormonal therapy
(3)radiation: more than 14 days passed after radiation.
7.expected survival longer than 3 months
8.With ability of oral intake
9.Sufficient function of important organs within 7 days prior to entry
(1)WBC between 3,000/mm3 and 12,000/mm3
(2)Granulocyte count 1,500/mm3 or over
(3)Platelet count 100,000/mm3 or over
(4)Hb 9.0 g/dL or over
(5)Total bilirubin <= the upper limit of normal range in each institute
(6)AST(GOT) <=2.5 times of the upper limit of normal range in each institute
(7)ALT(GPT) <=2.5 times of the upper limit of normal range in each institute
(8)Serum creatinine <= the upper limit of normal range in each institute
(9)Left ventricle ejection fraction 50 % or over by cardiac sonography or MUGA scan
(10)Ccr: >=50 ml/min
10.Written informed consent to participate
Key exclusion criteria 1.With contraindicate TS-1, CPT-11 and Trastuzumab
2.With active double cancer
3.With uncontrolled diabetes
4.Heart failure with clinically problem
5.Symptomatic brain metastasis
6.With mental disorder which become problem on clinical practice
7.With uncontrolled hypertension
8.Physician judged improper to entry this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi,Kurume city,Fukuoka
TEL 0942-35-3311
Email utoh@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi
TEL 0942-31-7566
Homepage URL
Email utoh@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Kurume 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

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Terminated
Date of protocol fixation
2010 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010159

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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