UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000416 |
|---|---|
| Receipt number | R000000504 |
| Scientific Title | Randomized study of Taxane vs TS-1 in metastatic or recurrent breast cancer patients |
| Date of disclosure of the study information | 2006/06/01 |
| Last modified on | 2014/10/14 15:55:01 |
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Basic information
Public title
Randomized study of Taxane vs TS-1 in metastatic or recurrent breast cancer patients
Acronym
Selection of effective chemotherapy for breast cancer (SELECT BC)
Scientific Title
Randomized study of Taxane vs TS-1 in metastatic or recurrent breast cancer patients
Scientific Title:Acronym
Selection of effective chemotherapy for breast cancer (SELECT BC)
Region
| Japan |
Condition
Condition
Metastatic or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test equivalency or non-inferiority in overall survival between Taxane and TS-1 in metastatic or recurrent breast cancer patients in case primary administration drug is either Taxane or TS-1 and secondary administration drug selection is left to doctor's decision
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Progression-Free Survival
Time To Treatment Failure
Adverse Events
Hearth-Related QOL
Efficacy of medical economy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taxane arm is given one administration chosen from below three pattern of administration by doctor. We repeat it 6 cycles or till cancer becomes worse.
(1) Dosetaxel 60-75mg/m2 (one cycle: 3 or 4 weeks interval adoministration)
(2) Paclitaxel 175mg/m2 (one cycle: 3 or 4 weeks interval adoministration)
(3) Paclitaxel 175mg/m2 (one cycle: every 3 week administration continuously followed by 1 week rest period)
Interventions/Control_2
TS-1 arm is given 40-60mg/m2 (adjusted to body surface) TS-1 administration 2 times/day (morning and evening) for 28 days continuously followed by 14 days rest period. Total 6 weeks is regarded as one cycle. We repeated it 4 cycles or till cancer becomes worse.
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)Histologically proven breast cancer
2)(a)Distant metastasis (Stage IV) in first diagnosis or (b) Proven metastatic or recurrent breast cancer after treatment by distant metastasis
3)At least one assessable lesion
4)No prior chemotherapy
5)ECOG performance status 0-1
6)(a)No prior Taxane administration or (b)Having passed at least 6 months since last Taxane administration
7)(a)No prior 5-FU administration or (b)Having passed more than 6 months since last 5-FU administration
8)Having passed more than 7 days since last hormonal therapy and more than 14 days since last radiation therapy
9)(a)Estrogen receptor(-) and progesterone receptor(-) in test of primary or recurrent lesion, (b) Ineffective primary hormonal therapy after metastasis or recurrence or (c)Metastasis or recurrence during postoperative adjuvant hormone therapy or within 6 months after last hormone therapy
10)Neutrophilic leukocyte>=1,500 or WBC>=3,000, PLT>=100,000, T-B<=(every institution's reference value)*2.5, AST(GOT)<=(every institution's reference value)*2.5, CRE<=(every institution's reference value) (these values are examined within 21 days before registration for this study)
11)No cardiac disease or no limitation of physical activity due to cardiac disease
12)Written informed consent
Key exclusion criteria
1)During pregnancy or lactation, or planning to get pregnant
2)HER2(Her2/neu, Erb B2) IHC (3+) or FISH(fluorescence in situ hybridization) (+) at primary or metastatic lesion
3)Anaphylaxis against medicine or solvent of this protocol treatment
4)Active double cancers
5)Brain metastasis which needs treatment for hyperfunction of intracranial pressure or urgent irradiation
6)Extended liver metastasis or lymphatic lung metastasis with dyspnea
7)Only one assessable lesion having past radiation therapy
8)Retention of pleural fluid, ascites and pericardial fluid which need urgent treatment
9)Active infectious disease
10)Interstitial pneumonia or idiopathic interstitial pneumonia
11)HBs(+)
12)Diabetes mellitus in bad control or during insulin treatment
13)Mental disease with difficulty of taking part in this study
14)Patients judged inappropriate for this study by the physicians
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Mukai |
Organization
National Cancer Center East Hospital
Division name
Department of Chemotherapy
Zip code
Address
6-5-1, Kasiwanoha, Kashiwa-shi, Chiba-ken, 227-8577, Japan
TEL
04-7133-1111
no@nomail
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shizuhiro Yamada |
Organization
Public Health research Foundation
Division name
Comprehensive Support Project for Clinical Research
Zip code
Address
1-1-7, Nishiwaseda, Shinjyuku-ku Tokyo, 169-0051 JAPAN
TEL
03-5287-2633
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
SELECT BC executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2006 | 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
Completed
Date of protocol fixation
| 2006 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2006 | Year | 05 | Month | 10 | Day |
Last modified on
| 2014 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000504
