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 UMIN000004764
Receipt No. 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

* 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 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
Email

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
Email

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005671

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.