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.