Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors

A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast.
• Metastatic disease must be measurable or evaluable
• Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
• NSAI given as adjuvant therapy that lasted ≥ 12 months OR
• Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
• Female postmenopausal patients

Exclusion Criteria:

• Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
• Prescribed Tamoxifen for metastatic disease
• Rapidly progressive visceral disease
• Patients with malignancies within the last 5 years.