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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011049
Receipt No. R000012932
Scientific Title Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Date of disclosure of the study information 2013/06/26
Last modified on 2019/02/04

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Basic information
Public title Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Acronym Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Scientific Title Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Scientific Title:Acronym Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 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 The purpose of this study was to assess the safety of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes adverse event
Key secondary outcomes response rate, progression free survival

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 S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest.
Trastuzumab 6 mg/kg* administered intravenously on day 1 of each 3-week cycle
*:8 mg/kg for the initial dosing
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

Not applicable
Gender Female
Key inclusion criteria 1) Histological and/or cytological confirmed breast cancer
2) HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods
3) ECOG performance status 0-2
4) Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan)
5) Age 20 or over
6) Adequate function of important organs (within 14 days before registaration)
1. WBC: >=4,000/mm3
2. Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T-Bil <= 1.5mg/dL
6. AST <= ULN x 2.5
7. ALT <= ULN x 2.5
8. Creatinin <= 1.5mg/dL
9.Ccr: >=60mL/min
7) Expected survival time: more than 6 months
8) Written informed consent
Key exclusion criteria 1) History of hypersensitivity reaction
2) Sever bone marrow suppression, renal dysfunction, liver dysfunction
3) Received S-1
4) Inflammatory breast cancer
5) Active double cancer
6) With widespread liver metastases or with dyspnea in pulmonary lymphangitis
7) With brain metastasis
8) With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease
9) Insulin therapy or Uncontrolled diabetes
10) With pulmonary fibrosis or pneumonitis
11) With dyspnea at rest
12) With pleural effusion, ascites, pericardial effusion
13) Active infection or potentiality infection
14) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
15) Judged ineligible based on physicians' decision
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Seki
Organization Kitasato University Kitasato Institute Hospital
Division name Breast Center
Zip code
Address Shirokane5-9-1 Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University Kitasato Institute Hospital
Division name Breast Center
Zip code
Address Shirokane5-9-1 Minato-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization Kitasato University Kitasato Institute Hospital
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
2013 Year 06 Month 26 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 Terminated
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
2019 Year 02 Month 04 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 26 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012932

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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