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Brief Title: Zoladex Plus Tamoxifen in Breast Cancer
Official Title: The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer
Study ID: NCT00827307
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Name: Hong-Jian Yang, MD.
Affiliation: Zhejiang Provicial Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Xiang-Yun Zong, MD., PhD.
Affiliation: Zhejiang Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR