NCT00065325
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Exemestane
- Conditions
- Locally Advanced Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 694
- Locations
- 1
- Primary Endpoint
- Time to disease progression (TTP)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
1
Exemestane
Intervention: Exemestane
2
Fulvestrant
Intervention: Fulvestrant
Outcomes
Primary Outcomes
Time to disease progression (TTP)
Time Frame: after 580 Progression events accrued
Secondary Outcomes
- Overall survival(after 580 Progression events accrued)
- Objective response rate(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)
Study Sites (1)
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