NIPH Clinical Trials Search

UMIN ID: C000000056

Registered date:12/08/2005

Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHormone-responsive postmenopausal primary breast cancer
Date of first enrollment2002/11/01
Target sample size2500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)TAM:Tamoxifen alone (total 5 years) ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 5 years)


Primary OutcomeDisease-Free Survival Adverse Events
Secondary OutcomeRelapse-Free Survival Overall Survival Health-Related QOL Efficacy of medical economy

Key inclusion & exclusion criteria

Age minimum65years-old
Age maximumNot applicable
Include criteria(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
Exclude criteria(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

Related Information


public contact
Name Akira Yamao
Address 1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051 JAPAN Japan
Telephone 03-5287-2633
Affiliation Public Health Research Foundation Comprehensive Support Project for Clinical Research
scientific contact
Name Tomohiko Aihara
Address 3-3-20, Makiochi, Minoo-shi, Osaka, 562-0004, Japan Japan
Telephone 072-723-9001
E-mail no@mail
Affiliation Aihara Hospital Department of Breast