Zoladex Plus Tamoxifen in Breast Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Goserelin; Tamoxifen

Criteria

Inclusion Criteria:

• provision of informed consent

• histologically proven HR+ operable invasive breast cancer

• completion of surgery and chemotherapy(if given).

• women defined as pre- or perimenopausal according to all of the following: aged 50 years or younger, at least one menstrual period during the last months.

Exclusion Criteria:

• clinical evidence of metastatic disease

• pregnancy or breast-feeding

• bilateral oophorectomy;

• radiation of the ovaries

• patients who, for whatever reason(eg, confusion, infirmity,alcoholism),are unlikely to comply with trial requirements

• patients whose chemotherapy was started more than 8 weeks after completion of primary surgery or whose chemotherapy was completed more than 8 weeks before starting the study treatment. Chemotherapy, if given, should have been given post-operatively, ie, patients who received neoadjuvant chemotherapy are ineligible

• patients who have not received chemotherapy and whose primary surgery was completed more than 8 weeks before starting the study treatment

• previous hormonal therapy as adjuvant treatment for breast cancer

• patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop

• previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied

• treatment with a non-approved or experimental drug during 1 month before entry into the study

• history of hypersensitivity to active or inactive excipients of tamoxifen and Zoladex

• history of bleeding diathesis (ie. Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )

• leukopenia and/or thrombocytopenia

• history of ocular fundus diseases

• history of thromboembolic diseases