UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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	Toru Watanabe
Organization	Hamamatsu Oncology Center
Division name	Department of Oncology
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	Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2001 Year 09 Month 21 Day
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

Related information
URL releasing protocol	http://www.csp.or.jp/
Publication of results	Unpublished
URL releasing results
Results
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