A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

Inclusion Criteria: * Histologically confirmed advanced or metastatic breast cancer * postmenopausal females with amenorrhoea \> 12 months and an intact uterus * FSH levels within postmenopausal range or have undergone a bilateral oophorectomy * ER \&/or PR positive * previous adjuvant hormone therapy \> 12 months prior to enrolment * previous adjuvant chemotherapy \> 6 months prior to enrolment * measurable disease according to RECIST and/or non measurable bone disease * life expectancy of at least 12 weeks * World Health Organisation (WHO) performance status (PS) of 0 to 1. Exclusion Criteria: * Male * life-threatening metastatic visceral disease * evidence of clinically active interstitial lung disease * ER and PR negative * treatment with LHRH analogues \< 3 months prior to enrolment * patients who have restarted menses or do not have FSH levels within the postmenopausal range * treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months * Treatment with hormonotherapy and/or chemotherapy for advanced disease * extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. \>30% of bone marrow, e.g. whole of pelvis or half of spine) * currently receiving oestrogen replacement therapy * treatment with a non-approved or experimental drug within 4 weeks before enrolment * absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy * any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known * severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.