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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000416
Receipt No. 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

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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
Email 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/
Email support@csp.or.jp

Sponsor
Institute SELECT BC executive committee
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000504

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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