Unique ID issued by UMIN | C000000056 |
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Receipt number | R000000046 |
Scientific Title | Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients |
Date of disclosure of the study information | 2005/08/12 |
Last modified on | 2016/02/19 14:36:07 |
Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 03)
Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 03)
Japan |
Hormone-responsive postmenopausal primary breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To test equivalency or superiority of Anastorozole to Tamoxifen by changing from Tamoxifen Alone
Bio-equivalence
Confirmatory
Pragmatic
Phase III
Disease-Free Survival
Adverse Events
Relapse-Free Survival
Overall Survival
Health-Related QOL
Efficacy of medical economy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
TAM:Tamoxifen alone (total 5 years)
ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 5 years)
65 | years-old | <= |
Not applicable |
Female
(1)Histologically proven invasive breast cancer, postoperative primary breast cancer, postmenopausal before registration (Postmenopausal is defined as (a)age>=60, (b)age>=45, amenorrhea more than 1 year 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)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)
(5)Taken Tamoxifen as postoperative adjuvant therapy for 1-4 years (need good compliance of patient)
(6)PS(ECOG) 0,1
(7)The results of tests below within last 6 months indicate no relapse and no contralateral breast cancer. (a)X-ray photo or CT of the breast,(b)Ultrasonography or CT of the abdomen,(c)Scintigraphy or X-ray photo of bone(thoracic vertebrae, lumbar vertebrae, pelvis and the other parts of paining),(d)Mammography of both side
(8)Relations to other treatments are (a)postoperative adjuvant treatment(chemotherapy or endocrinotherapy) is started within 12 weeks after mastectomy/ breast-conserving surgery,(b)postoperative chemotherapy finished till registration,(c)only Tamoxifen is permitted as pre-operative endocrinotherapy (pre-operative chemotherapy is permitted)
(9)WBC>3,000, PLT>100,000, Hb>=9.0, T-B=<1.5, GOT,GPT=<(every institution's reference value)*2.5, CRE=<1.5 (these values are tested within 8 weeks before registration), no past cardiac infraction or congestive heart failure, no ischemic heart disease or valvular disease needed to be treated
(10)Written informed consent
(1)Invasive carcinoma of other organs (less than 5years after the last treatment)
(2)Metachronous or synchronous bilateral breast cancer
(3)Past deep venous embolism
(4)Osteoporosis needed to be treated or past bone fracture because of osteoporosis
(5)Patients judged inappropriate for this study by the physicians
2500
1st name | |
Middle name | |
Last name | Tomohiko Aihara |
Aihara Hospital
Department of Breast
3-3-20, Makiochi, Minoo-shi, Osaka, 562-0004, Japan
072-723-9001
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 03 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
2002 | Year | 10 | Month | 08 | Day |
2002 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
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=R000000046
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