The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer

Exclusion Criteria

• •1. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
• •2. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
• •* Age .60 years
• •* Prior bilateral oophorectomy
• •* Age\<60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and estradiol in the postmenopausal range(according to local sites).
• •* If taking tamoxifen or toremifene, and age\<60 years, then FSH and plasma estradiol level in postmenopausal ranges(according to local sites).
• •3. More than one regimen of chemotherapy for advanced disease.
• •4. Previous endocrine therapy for advanced disease.
• •5. Prior treatment with an aromatase inhibitor or fulvestrant.
• •6. Prior treatment with a GnRHa within 3 months.
• •7. Treatment with a non-approved or experimental drug within 4 weeks before randomisation.
• •8. Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
• •9. History of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency), or long-term anticoagulant therapy.
• •10. Known hypersensitivity to the active substance or to any of the excipients of this product, or other GnRHa.
• •11. HER-2 over-expressing breast cancer and concomitant trastuzumab treatment.
• •12. Pregnancy and lactation.
• •13. Any severe concomitant condition which makes it undesirable for the patient to participate in t he trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease, uncontrolled diabetes mellitus, severe osteoporosis or renal failure and so on .
• •14. Inadequate organ function