UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000055 |
|---|---|
| Receipt number | R000000042 |
| Scientific Title | Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel- |
| Date of disclosure of the study information | 2005/08/12 |
| Last modified on | 2018/10/03 16:56:15 |
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Basic information
Public title
Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel-
Acronym
Phase III Randomized Adjuvant Study of chemotherapy in Node Positive Breast Cancer Patients (N-SAS BC 02)
Scientific Title
Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel-
Scientific Title:Acronym
Phase III Randomized Adjuvant Study of chemotherapy in Node Positive Breast Cancer Patients (N-SAS BC 02)
Region
| Japan |
Condition
Condition
node positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test non-inferiority of Taxane alone to Anthracycline-Cyclophosphamide and Taxane, To test superiority or Equivalency between Paclitaxel and Dosetaxel
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-Free Survival
Key secondary outcomes
Relapse-Free Survival
Overall Survival
Health-related QOL
Adverse Events
Efficacy of medical economy
Base
Study type
Interventional
Study design
Basic design
Factorial
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ACP : Adriamycin 60mg/m2 or Epirubicin 75mg/m2 (30min. drip phleboclysis, day1) + Cyclophosphamide 600mg/m2 (60min. drip phleboclysis, day1) 4 cycles followed by Paclitaxel 175g/m2 (3 hours drip phleboclysis, day1) 4 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
Interventions/Control_2
ACD : Adriamycin 60mg/m2 or Epirubicin 75mg/m2 (30min. drip phleboclysis, day1) + Cyclophosphamide 600mg/m2 (60min. drip phleboclysis, day1) 4 cycles followed by Dosetaxel 75g/m2 (1 hour drip phleboclysis, day1) 4 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
Interventions/Control_3
PTX : Paclitaxel 175g/m2 (3 hours drip phleboclysis, day1) 8 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
Interventions/Control_4
DTX : Dosetaxel 75g/m2 (1 hour drip phleboclysis, day1) 8 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Histologically proven primary breast cancer
(2)StageI,IIA,IIIB,IIIA (TNM staging system)
(3)Proven node positive by node dissection or sentinel node biopsy
(4)PS (Eastern Cooperative Oncology Group performance status scale) 0,1
(5)Relations to other treatments are (a)Treatment of this study started within 12 weeks after mastectomy/breast-conserving surgery or node dissection, (b)No postoperative radiation, and (c)No endocrinotherapy, chemotherapy
(6)WBC>=4,000 or neutrophilic leukocyte>=2,000, PLT>=100,000,T-B=<1.5 , GPT(ALT)=<(every institution's reference value)*2.5, CRE<=1.5 (these values are tested within 2 weeks before registration for this study), no cardiac infraction or congestive heart failure, no grave ischemic heart disease or valvular disease
(7)Written informed consent
Key exclusion criteria
(1)During pregnancy or lactation
(2)Double invasive carcinoma(less than 5 years after the last treatment)
(3)Metachronous bilateral breast cancer
(4)Anaphylaxis against medicine using cremophor EL(polyoxethylated castor oil) or polysorbate as a solvent
(5)Patients judged inappropriate for this study by the physicians
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Watanabe |
Organization
Hamamatsu Oncology Center
Division name
Department of Oncology
Zip code
Address
Hamamatsu Oncology Center Building 1F,3-6-13 ,Chuo,Naka-ku, Hamamatsu-shi,Shizuoka,430-0929,Japan
TEL
053-452-6940
no@mail
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
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
N-SAS BC 02 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
| 2005 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
http://www.csp.or.jp/
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
| 2001 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2005 | Year | 08 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000042
