The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of breast density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.
After the completion of primary treatment(surgery and/or adjuvant chemotherapy, radiotherapy could be given concurrently with study medication), eligible patients will be randomized to receive Zoladex plus tamoxifen or tamoxifen alone. The duration of study medication along with the follow-up will be 18 months, or until disease recurrence,or discontinuation of study therapy (as a result of an adverse event, a patient's request, or an investigator's decision), further treatment will be at investigator's discretion. During the study period, contralateral mammograms and transvaginal ultrasound will be undertaken at baseline and after 6, 12 and 18 months of study medications. Mammographic density assessment will be undertaken by a single radiologist. Serum measurements including estrogen levels and lipidemia will be obtained at baseline and after 3, 6, 12 and 18 months of study medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Mammographic percentage density at 18months
Time frame: 18months after enrolled
estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities
Time frame: 3,6,12,18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.