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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anastrozole; Aromatase Inhibitors; Estradiol; Exemestane; Fulvestrant

Criteria

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.