Zoladex Plus Tamoxifen in Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00827307
Study type	Interventional
Source	Zhejiang Cancer Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 2008
Completion date	August 2011

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