To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
patients will take toremifene 60 mg qd.
patients will take tamoxifen 10 mg bid.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
incidence of ovarian cyst
Ovarian cyst is defined as a purely liquid-filled structure that was equal to or exceeded 2 cm in its largest diameter detected by transvaginal ultrasonography.Participants will be required to receive transvaginal ultrasonography every 3 months.
Time frame: participants will be followed during the first year of endocrine therapy
incidence of endometrial thickening
Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months.
Time frame: participants will be followed during the first year of endocrine therapy
change of female hormones
Change of follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months
Time frame: participants will be followed during the first year of endocrine therapy
change of blood lipid
Change of blood lipid as measured every 3 months
Time frame: participants will be followed during the first year of endocrine therapy
change of liver function
change of blood lipid as measured every 3 months
Time frame: participants will be followed during the first year of endocrine therapy
incidence of fatty liver
Incidence of fatty liver as examined by liver ultrasound every 3 months.
Time frame: participants will be followed during the first year of endocrine therapy
change of Kupperman index
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change of Kupperman index as measured every 3 months.
Time frame: participants will be followed during the first year of endocrine therapy