hormone-responsive postmenopausal primary breast cancer
Conditions
Interventions
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
Sponsors
N-SAS BC 04 executive committee
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival after a lapse of 2.5-3 years Quantity of lipid metabolic Bone mineral content | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public Health Research Foundation Comprehensive Support Project for Clinical Research
Outcome results
None listed