UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017034 |
|---|---|
| Receipt number | R000019750 |
| Scientific Title | A Phase II trial of alternate-day S-1 for anthracyclin･taxane refractory metastatic breast cancer |
| Date of disclosure of the study information | 2015/04/03 |
| Last modified on | 2015/04/03 14:19:53 |
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Basic information
Public title
A Phase II trial of alternate-day S-1 for anthracyclin･taxane refractory metastatic breast cancer
Acronym
SALT-BC trial
Scientific Title
A Phase II trial of alternate-day S-1 for anthracyclin･taxane refractory metastatic breast cancer
Scientific Title:Acronym
SALT-BC trial
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 alternate-day S-1 for anthracyclin･taxane pretreatment metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival(PFS)
Key secondary outcomes
Response rate(RR)
Overall survival(OS)
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of alternata-day S-1 for metastatic breast cancer.
[Alternate-day S-1]
･Oral S-1 administration is Alternate-day about 80-120mg/day depending on body surface area.
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
･Female unresectable metastatic or recurrence breast cancer.
･Histologically confirmed invasive breast cancer.
･At least one evaluable lesion.
･Evaluated ER and PgR status by IHC.
･Evaluated HER2(-) by IHC/FISH.
･Prior treatment of anthracyclin/taxane.
･20 to 75 years old at diagnosis.
･Adequate major organ function.
･WBC>=3,000/mm3 or Neu>=1,500/mm3
･Plt>=100,000 /mm3
･Hb>=9.0 g/dL
･AST/ALT <=ULN*2.5
･Bil<=ULN*1.5
･Cr<=ULN*1.5
･CCr>=60mL/min
･Performance status(ECOG) 0 or 2
･Non life threatening.
･Written informed consent.
Key exclusion criteria
･History of drug-hypersensitivity.
･Evaluated HER2(+) by IHC/FISH.
･Active double cancer.
･Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
･Male patient.
･Infection or suspected infection.
･Abnormal ECG or serious cardiac disorder.
･History of congestive cardiac failure.(NYHA class III/IV)
･Complication needed hospitalization.
･Administration of flucytosine phenytoin or warfarin potassium.
･Mental disease with difficulty of taking part in this study.
･Administration of steroid.
･HBV related marker (+).
･Gastrointestinal bleeding.
･Current pregnancy and lactation, or possibility of pregnancy.
･Ineligible based on decision of an investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kameoka |
Organization
Tokyo Women`s Medical University
Division name
Department of Surgery II.
Zip code
Address
8-1, Kawada-chou, Shinjuku-ku, Tokyo, Japan.
TEL
+81-3-3353-8111
nigeikyoku@surg2.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Ohchi |
Organization
Tokyo Women`s Medical University
Division name
Department of Surgery II.
Zip code
Address
8-1, Kawada-chou, Shinjuku-ku, Tokyo, Japan.
TEL
+81-3-3353-8111
Homepage URL
ohchi@surg2.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women`s Medical University
Department of Surgery II
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 04 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2015 | Year | 04 | Month | 03 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019750
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
