Unique ID issued by UMIN | C000000057 |
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Receipt number | R000000053 |
Scientific Title | 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 14:38:11 |
Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 04)
Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 04)
Japan |
hormone-responsive postmenopausal primary breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
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
Bio-equivalence
Confirmatory
Pragmatic
Phase III
Relapse-Free Survival after a lapse of 2.5-3 years
Quantity of lipid metabolic
Bone mineral content
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
3
Treatment
Medicine |
EXE : Exemestane for 5 years
TAM : Tamoxifen for 2.5-3 years followed by Exemestane for 2.5-3 years (control)
ANA : Anastrozole for 5 years
60 | years-old | <= |
Not applicable |
Female
(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
(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
300
1st name | |
Middle name | |
Last name | Yasuo Hozumi |
Jichi Medical School
Department of Mammary gland/General Surgery
3311-1, Yakushiji, Minamikouchi-cho, Kouchi-gun, Tochigi, 329-0498, Japan
0285-58-7371
no@mail
1st name | |
Middle name | |
Last name | Akira Yamao |
Public Health Research Foundation
Comprehensive Support Project for Clinical Research
1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051 JAPAN
03-5287-2633
http://www.csp.or.jp/
support@csp.or.jp
N-SAS BC 04 executive committee
Public Health Research Foundation
Non profit foundation
Japan
NO
2005 | Year | 08 | Month | 12 | Day |
http://www.csp.or.jp/
Partially published
http://www.springerlink.com/content/20751q2755g2n641/
Completed
2003 | Year | 08 | Month | 29 | Day |
2003 | Year | 09 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
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.
2005 | Year | 08 | Month | 12 | Day |
2016 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000053
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