UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014096 |
|---|---|
| Receipt number | R000015964 |
| Scientific Title | A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2018/03/05 18:27:19 |
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Basic information
Public title
A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer
Acronym
A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Scientific Title
A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer
Scientific Title:Acronym
A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Disease control rate
Progression-free survival
Time to failure
Adverse events
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 at a dose of 40-60 mg (80-120 mg/day), depending on the BSA and creatinine-clearance from days 1 to 14, which is followed by 7 days rest.
This treatment is repeated until disease progressive.
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)Histologically confermed breast cancer patients of female
(2)Metastatic or recurrent breast cancer.
1) Patients with distant metastasis of breast cancer.
2) Refractory or recurrent breast cancer. Local recurrence is excluded.
(3) Patients submitted written informed consent to participate in this clinical study.
(4)Patients with measurable lesions based on RECIST v.1.1.
(5) no prior chemotherapy or 1 to 2 regimens for metastatic or recurrent breast cancer.
(6) Eastern Cooperative Oncology Group performance status 0,1
(7)
1)previously treated with no orally-administered fluorinated pyrimidine
2)more than 24weeks interval after adjuvant or neoadjuvant chemotherapy of orally-administered fluorinated pyrimidine
(8) The values of laboratory findings within 21 days prior to registration meet all the criteria listed below.
1) neutrophil count: >=1,500/mm3 or leucocytes count: >=3,000/mm3
2)platelet count: >=100,000/mm3
3)total-billirubin:<=2.5 times the upper limit of center standard.
4) AST(GOT)and ALT(GPT): <=2.5 times the upper limit of center standard
5) serum creatinine : within the upper limit of center standard
Key exclusion criteria
(1) HER2 positive (IHC:3+ or FISH +)
(2) History of non-breast malignancies within the 5 years prior to study entry
(3) Symptomatic brain metastasis
(4) Diffuse liver meta, or carcinomatous lymphangitis.
(5) In addition, the case that a investigator judged to
be inadequate
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Shimizu |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Department of Breast Surgery
Zip code
Address
Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
shimitsu@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hirano |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Department of Breast Surgery
Zip code
Address
Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
Homepage URL
ahirasu@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
東京女子医科大学東医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015964
