UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004764 |
|---|---|
| Receipt number | R000005671 |
| Scientific Title | Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2010/12/21 14:28:33 |
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Basic information
Public title
Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer
Acronym
Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer
Scientific Title
Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer
Scientific Title:Acronym
Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Step 1 part: To evaluate the feasibility and pharmacokinetics of TS-1 plus Trastuzumab combination chemotherapy in patients with metastatic breast cancer.
Step 2 part: To evaluate the efficacy and toxicity of TS-1 plus Ttrastuzumab combination chemotherapy in patients with metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Step 1 part: safety, feasibility
Step 2 part: response rate, safety
Key secondary outcomes
Step 1: Pharmacokinetics of TS-1
Step 2: TTP, TTF, OS
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 (80 mg/m2/day, day 1 through 14), Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for subsequent administration, day1, 8, 15). 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) Pathologically confirmed breast cancer who diagnosed
2) metastatic breast cancer
3) age: >=20 and <=75
4) Her2 positive
5) No-carry-over effect of prior treatment
6) patients with measurable region
7) Performance Status: 0-2(ECOG)
8) left ventricular ejection fraction: normal range in institute
9) sufficient function of important organs
a) WBC: >=4,000/mm3, <=12,000/mm3
b) Neutrophyl: >=2,000/mm3
c) Platelet: >=100,000/mm3
d) Hemoglobin: >=9g/dl
e) ALT, AST: < 2.5 times of the upper limit of normal range in each institute
f) sT.bil: <= the upper limit of normal range in each institute
g) sCreatinin: <= the upper limit of normal range in each institute
h) Ccr: >=60 ml/min/body
10) expected more than 3 months survival from drug administration
11)written informed consent
12)with ability of oral intake
Key exclusion criteria
1) with severe allergy to Trastuzumab and TS-1 and 5-FU based drug
2) with history of severe allergy
3) pregnant or nursing women
4) with wide liver metastasis or lymphangitic pulmonary metastasis with respiratory distress
5) with active double cancer
6) with cerebral metastasis
7) with metastatic lesions observed only in their bones
8) with uncontrollable heart failure,
angina pectoris, congestive cardiac failure, history of myocardial infarction, abnormal cardiac rhythm which need to treat
9) uncontrolled diabetes
10) with pulmonary fibrosis or pneumonitis
11) with dyspnea at rest
12) with uncontrolled pleural effusion, peritoneal effusion, pericardial effusion
13) possible infection associated with clinical symptoms such as fever
14) doctor's decision not to be registered to this study
Target sample size
30
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
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
Homepage URL
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
| 2010 | Year | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2006 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2010 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005671
