A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Inclusion Criteria:

- Histological confirmation of breast cancer in post menopausal women (age >=60).
Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic
tumour tissue based on local laboratory assessment.

- EITHER locally advanced disease (1 line of chemotherapy allowed only if remain
unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of
chemotherapy for breast cancer allowed only if subsequent evidence of further
progressive disease)

- At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed
at baseline and is suitable for repeated assessment.

- Postmenopausal women, fulfilling 1 of:

- Prior bilateral oophorectomy

- Age >60 years

- Age < 60 years and amenorrheic for 12+months in the absence of chemotherapy,
tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the
postmenopausal range

Exclusion Criteria:

- Presence of life-threatening metastatic disease

- Any of:

- Extensive hepatic involvement

- involving brain or meninges

- symptomatic pulmonary lymph spread

- Discrete lung metastases are acceptable if respiratory function is not significantly
compromised

- Prior systemic therapy for breast cancer other than one line of cytotoxic
chemotherapy (the last dose of chemotherapy must have been received more than 28 days
prior to randomisation)

- Radiation therapy if not completed within 28 days prior to randomisation (with the
exception of radiotherapy given for control of bone pain, started prior to
randomisation). Prior hormonal treatment for breast cancer.

- 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).