UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008647 |
|---|---|
| Receipt number | 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 18:34:43 |
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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
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
utoh@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010159
