The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Official Title
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A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

Conditions
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Locally Advanced Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant
* Drug: Exemestane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy confirmation of Breast Cancer Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor Postmenopausal women defined as a women who has stopped having menstrual periods Evidence of hormone sensitivity Written informed consent to participate in the trial Exclusion Criteria: Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane) Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor Treatment with an investigational or non-approved drug within one month An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 91 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Exemestane | Drug: Exemestane<br>* oral capsule<br>* Other names: AROMASIN™;|
| Experimental: 2<br>Fulvestrant | Drug: Fulvestrant<br>* intramuscular injection<br>* Other names: ZD9238;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression (TTP) |  | after 580 Progression events accrued | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | after 580 Progression events accrued | 
| Overall survival |  | after 580 Progression events accrued | 
| Duration of response |  | after 580 Progression events accrued | 
| Clinical Benefit |  | after 580 Progression events accrued | 
| Quality of Life |  | after 580 Progression events accrued | 
| PK |  | each visit | 
| Safety and tolerability. |  | after 580 Progression events accrued | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced breast cancer, metastatic breast cancer, Breast Cancer, Cancer of Breast, Cancer of the Breast