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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Progression-free Survival

Treatments: Drug: anastrozole; Drug: exemestane; Drug: fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944918

9238UK/0005

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups

1

Experimental group

Description:

fulvestrant and anastrozole

Treatment:

Drug: fulvestrant

Drug: anastrozole

2

Experimental group

Description:

fulvestrant and placebo

Treatment:

Drug: fulvestrant

3

Active Comparator group

Description:

exemestane alone

Treatment:

Drug: exemestane