UMIN-CTR Clinical Trial


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Recruitment
status
No longer recruiting
Unique trial Number : C000000057
Title of the study : Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Date of formal registration
(=Date of ICMJE and WHO compliant trial information registration and disclosure)
: 2005/08/12
Date and time of last update : 2014/03/03 16:50:26

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
Item Value
Official scientific title of the study Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Title of the study (Brief title) Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 04)
Region Japan


Condition
Item Value
Condition hormone-responsive postmenopausal primary breast cancer
Classification by specialty Hematology and clinical oncology
Breast surgery
Classification by malignancy Malignancy
Genomic information NO


Objectives
Item Value
Narrative objectives1 To test equivalency of effect among Tamoxifen followed by Exemestane, Anastrozole and Exemestane on bone mineral content and lipid, especially (1)equivalency of Exemestane and Anastrozole to Tamoxifen followed by Exemestane (2)difference between Anasorozole and Exemestane
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III


Assessment
Item Value
Primary outcomes Relapse-Free Survival after a lapse of 2.5-3 years
Quantity of lipid metabolic
Bone mineral content
Key secondary outcomes Relapse-Free Survival after a lapse of 5 years
Overall Survival
Rate of contralateral breat cancer
Adverse events
Long-term tolerance
Function of blood coagulation and fibrinolysis
Health Related QOL


Base
Item Value
Study type Interventional


Study design
Item Value
Basic design Parallel
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
Item Value
No. of arms 3
Purpose of intervention Treatment
Type of intervention Medicine
Interventions/Control_1 EXE : Exemestane for 5 years
Interventions/Control_2 TAM : Tamoxifen for 2.5-3 years followed by Exemestane for 2.5-3 years (control)
Interventions/Control_3 ANA : Anastrozole for 5 years
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10


Eligibility
Item Value
Age-lower limit 60 years-old <=
Age-upper limit Not applicable
Gender Female
Key inclusion criteria (1)Histologically proven invasive breast cancer which is postoperative primary breast cancer and postmenopausal before registration (postmenopausal is defined as (a)age>=60, (b)age>=45, amenorrhea more than 1year without hysterectomy, or (c) double ovariectomy has done. The case which is premenopausal before operation and menopaused after chemotherapy or during Tamoxifen administration will be included.))
(2)StageI,IIA,IIB,IIIA,IIIB (TNM staging system)
(3) (a)node dissection has done, or (b) sentinel node biopsy has performed and diagnosis on H&E is negative
(4)Cases which meet one of the criteria (a)-(d) (a)diameter of invation>3cm, (b)pathologically node positive (pN+), (c)Nuclear Grade 3 by N-SAS BC Standard (in case of invasive lactiferous duct cancer), (d)invasive lobular carcinoma, epidermoid carcinoma or spindle cell carcinoma
(5)The result of hormone receptor test meets (a)-(c). (a)estrogen receptor(+) and progesterone receptor(+),(b)estrogen receptor(+) and progesterone receptor(-),(c)estrogen receptor(-) and progesterone receptor(+) (Take priority over the result of immune staining to EIA)
(6)PS(ECOG) 0,1
(7)Relations to other treatments are (a)postoperative chemotherapy finished till registration for this study, (b)no pre-operative chemotherapy, (c)no pre- and post-operative hormonal therapy
(8)WBC>3,000, PLT>100,000, GOT,GPT=<(every institution's reference value)*2.5, CRE=<1.5( these values are examined within 4 weeks before registration for this study), no on-going treatment of cerebral embolism, no past cardiac infraction or congestive heart failure, no ischemic heart disease or valvular disease needed to be treated
(9)Reference values (a)lipid:total cholesterol(TC)<260mg/dl and total neutral lipid<300mg/dl (fasting blood sampling), (b)bone mineral content:more than 70% of average of young person (at only institutions which are able to collect data about bone)
(10)Written informed consent
Key exclusion criteria (1)invasive carcinoma of other organs (less than 5 years after the last treatment)
(2)Past breast cancer
(3)Past deep venous embolism
(4)HRT(hormone replacement therapy) for symptoms of menopause within 4weeks before treatment
(5)Metachronous or synchronous bilateral breast cancer
(6)Patients judged inappropriate for this study by the physicians
Target sample size 300


Research contact person
Item Value
Name of lead principal investigator Yasuo Hozumi
Organization Jichi Medical School
Division name Department of Mammary gland/General Surgery
Address 3311-1, Yakushiji, Minamikouchi-cho, Kouchi-gun, Tochigi, 329-0498, Japan
TEL +81-285-58-7371
Email no@mail


Public contact
Item Value
Name of contact person Shizuhiro Yamada
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 +81-3-5287-2633
Homepage URL http://www.csp.or.jp/
Email support@csp.or.jp


Sponsor
Item Value
Name of primary sponsor N-SAS BC 04 executive committee

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.


Funding Source
Item Value
Source of funding Public Health Research Foundation
Category of Org. Non profit foundation
Nation of funding Japan


Other related organizations
Item Value
Name of secondary sponsor(s)
Name of secondary funder(s)


Secondary study IDs
Item Value
Secondary study IDs NO
Secondary study ID_1
Org. issuing Secondary study ID_1
Secondary study ID_2
Org. issuing Secondary study ID_2
IND to MHLW


Institutions
Item Value
Institutions


Progress
Item Value
Recruitment status No longer recruiting
Date of protocol fixation 2003/08/29
Anticipated trial start date 2003/09/01
Last follow-up date 2011/03/01
Date of closure to data entry
Date trial data considered complete
Date analysis concluded


Related information
Item Value
URL releasing protocol http://www.csp.or.jp/
Publication of results partially published
URL releasing results http://www.springerlink.com/content/20751q2755g2n641/
Results
Other related information Core-protocol of this trial is of TEAM trial, which purposes comparison between Exemestane(EXE) and Tamoxifen(TAM). Sub-protocol (Japan original) additionally purposes assessment of secondary effects (lipid metabolic, bone mineral, function of blood coagulation and fibrinolysis) and Health Related QOL among EXE, TAM and ANA. EXE and TAM of Sub-protocol are registered for Core-protocol too.


Item Value
Date of registration 2005/08/12
Date of last update 2014/03/03 16:50:26


Link to view
URL(Japanese) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000000053&type=summary&language=J
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000000053&type=summary&language=E
This page includes information on clinical trials registered in UMIN clinical trial registed system.
We don't aim to advertise certain products or treatments.