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

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 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


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

Value
https://center6.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