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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Progression-free Survival

Intervention / Treatment
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* Drug: fulvestrant
* Drug: anastrozole
* Drug: exemestane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fulvestrant and anastrozole | Drug: fulvestrant<br>* Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.<br>* Other names: Faslodex;Drug: anastrozole<br>* Tablet, oral, once daily until disease progression.<br>* Other names: Arimidex;|
| Experimental: 2<br>fulvestrant and placebo | Drug: fulvestrant<br>* Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.<br>* Other names: Faslodex;|
| Active Comparator: 3<br>exemestane alone | Drug: exemestane<br>* Tablet, oral, once daily until disease progression.<br>* Other names: Aromasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | every 3 months during treatment and, at time of discontinuation from treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer