UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000055
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email support@csp.or.jp

Sponsor
Institute N-SAS BC 02 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000042

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.