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

Phase 3

Completed

• Conditions: Progression-free Survival
• Interventions: Drug: fulvestrant; Drug: exemestane; Drug: anastrozole

• Registration Number: NCT00944918
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fulvestrant	fulvestrant and anastrozole
1	anastrozole	fulvestrant and anastrozole
2	fulvestrant	fulvestrant and placebo
3	exemestane	exemestane alone

Primary Outcome Measures

Name	Time	Method
Progression-free survival	every 3 months during treatment and, at time of discontinuation from treatment

Secondary Outcome Measures

Name	Time	Method
Objective complete response (CR) and partial response (PR) rate	every 3 months during treatment and, at time of discontinuation from treatment
Duration of response	every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate	every 3 months during treatment and, at time of discontinuation from treatment

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of