UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008879 |
|---|---|
| Receipt number | R000010415 |
| Scientific Title | A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer |
| Date of disclosure of the study information | 2012/09/07 |
| Last modified on | 2012/09/07 17:42:31 |
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Basic information
Public title
A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer
Acronym
A study of TS-1 alternate-day dosing for Breast cancer
Scientific Title
A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer
Scientific Title:Acronym
A study of TS-1 alternate-day dosing for Breast cancer
Region
| Japan |
Condition
Condition
Metastatic/Advanced Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TS-1 Alternate-day dosing with Metastatic/Advanced Breast Cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival (PFS)
Key secondary outcomes
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
Dose the TS-1 of 80mg/m2 in alternate-day.
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)Histologically confirmed primary breast cancer
2)Satisfies any of the following in a diagnosis of metastatic breast cancer.
1.Inoperable for distant metastasis in an initial diagnosis.
2.The cause that recurred or progressed is distant metastasis.
3)Evaluable lesions are at least one or more.
4)Received no previous chemotherapy, or only two regimen.
5)Age >= 20 years
6)ECOG performance status of 0 or 1
7)Hormonal therapies-resistant and Satisfies any of the following.
1.ER-negative breast cancer
2.Hormonal therapies-resistant in the therapy for metastatic breast cancer.
3.A recurrence during six months after adjuvant hormonal therapies or the surgery.
8)Satisfies all of the following about precedent treatment (including the adjuvant setting).
1.Pass more than 7 days, after the hormonal therapies end.
2.Pass more than 14 days, after the radiotherapy end.
9)Results from a laboratory test meet the following
WBC >= 3,500/mm3
Neu >= 2,000/mm3
Hb >= 9.0g/dL
Plt >= 100,000/mm3
T-Bil <= 1.5mg/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Cre <= 1.2mg/dL
Ccr >= 60mL/min
10)Be able to be administered orally.
11)Written informed consent.
Key exclusion criteria
1)Active double cancer.
2)Watery diarrhea.
3)Require administration of flucytosine, phenytoin, and warfarin.
4)The metastases to brain which require measures for the brain hypertension and urgent brain irradiation.
5)Extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea.
6)A lesion targeted for an evaluation is only one, and there is an enforcement history of the radiotherapy to the part.
7)Pleural effusion, ascitic fluid, pericardial effusion to need urgent treatment.
8)Severe infections being suspected.
9)Interstitial pneumonia or pulmonary fibrosis.
10)HBs antigen is positive.
11)The diabetes patients with difficult control or during treatment with insulin.
12)Serious mental disorder.
13)Pregnant woman, a nursing mother or has a hope for the pregnancy.
14)The patients who are inappropriate to the study which judged by doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Oura |
Organization
Wakayama Medical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama Medical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Homepage URL
Sponsor or person
Institute
Wakayama Medical University, Department of Thoracic and Cardiovascular Surgery
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
| 2012 | Year | 09 | Month | 07 | 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
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 07 | 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
| 2012 | Year | 09 | Month | 07 | Day |
Last modified on
| 2012 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010415
