UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000795 |
|---|---|
| Receipt number | R000000600 |
| Scientific Title | A randomized controlled study comparing Anastrozole+TS-1 as postoperative chemotherapy in ER positive metastatic breast cancer |
| Date of disclosure of the study information | 2007/08/12 |
| Last modified on | 2008/03/17 15:43:38 |
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Basic information
Public title
A randomized controlled study comparing Anastrozole+TS-1 as postoperative chemotherapy in ER positive metastatic breast cancer
Acronym
TS-1 and ANA combination therapy in Chugoku and Shikoku trial (TACS trial)
Scientific Title
A randomized controlled study comparing Anastrozole+TS-1 as postoperative chemotherapy in ER positive metastatic breast cancer
Scientific Title:Acronym
TS-1 and ANA combination therapy in Chugoku and Shikoku trial (TACS trial)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of Anastrozole+S-1 compared to Anastrozole alone in ER positive metastatic Breast Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival (OS), Disease free survival (DFS), Adverse events, Examination of the relevance of 5-FU relative factors (thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyl transferase (OPRT) mRNA) and HER2 profile with efficacy, Clinical benefit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: Anastrozole (1mg/day) is administratedd orally on days 1-21 until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(+) Breast cancer
Interventions/Control_2
Group B: Anastrozole (1mg/day) is administratedd orally on days 1-21 and S-1 (80mg/m2/day) is administrated orally on days 1-21 every 28 days until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(+) Breast cancer
Interventions/Control_3
Group C: Anastrozole (1mg/day) is administratedd orally on days 1-21 until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(-) Breast cancer
Interventions/Control_4
Group D: Anastrozole (1mg/day) is administratedd orally on days 1-21 and S-1 (80mg/m2/day) is administrated orally on days 1-21 every 28 days until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(-) Breast cancer
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Histologically confirmed Breast Cancer 2) Estrogen Respecter positive (10% cut off) 3) Performance Status (ECOG) 0-2 4) Measurable disease 5) Without prior chemotherapy nor use of Anastrozole 6) Adequate organ functions 7) Estimated life expectancy of at least 3 months 8) Postmenopausal 9) Oral intake is possible 10) Written informed consent
Key exclusion criteria
1) concomitant malignancy 2) patient with marked infection 3) patient with marked fever and suspected infection 4) patient with metastasis to CNS 5) complications including ischemic heart disease 6) Active gastrointestinal ulceration 7) Serious Neuropathy 8) Anarmnesis of drug allergy 9) Severe Bone marrow suppression 10) serious renal function disturbance 11) serious liver function disturbance 12) taking other fluoropyrimidine derivatives 13) Under treatment with flucytosine 14) Not suitable for participating in the study for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sonoo |
Organization
Kawasaki Medical School
Division name
Department of Breast and Thyroid Surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tanaka |
Organization
Kawasaki Medical School
Division name
Department of Breast and Thyroid Surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
tanakaka@med.kawassaki-m.ac.jp
Sponsor or person
Institute
Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2007 | Year | 08 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 09 | Day |
Last modified on
| 2008 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000600
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