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Recruitment status Completed
Unique ID issued by UMIN C000000057
Receipt No. R000000053
Official scientific title of the study Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Date of disclosure of the study information 2005/08/12
Last modified on 2016/02/19

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

Objectives
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
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
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
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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
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 0285-58-7371
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 04 executive committee
Institute
Department

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
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
2003 Year 08 Month 29 Day
Anticipated trial start date
2003 Year 09 Month 01 Day
Last follow-up date
2011 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 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.

Management information
Registered date
2005 Year 08 Month 12 Day
Last modified on
2016 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000053


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