The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mammographic percentage density at 18months
18months after enrolled
Hong-Jian Yang, MD.
Zhejiang Provicial Cancer Hospital
China: Ministry of Health