Locally Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
Locally advanced breast cancer, metastatic breast cancer, Breast Cancer, Cancer of Breast, Cancer of the Breast
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.
Interventions
DRUGFulvestrant
intramuscular injection
DRUGExemestane
oral capsule
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
32 Years to 91 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression (TTP) | after 580 Progression events accrued |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | after 580 Progression events accrued |
| Duration of response | after 580 Progression events accrued |
| Clinical Benefit | after 580 Progression events accrued |
| Objective response rate | after 580 Progression events accrued |
| PK | each visit |
| Safety and tolerability. | after 580 Progression events accrued |
| Quality of Life | after 580 Progression events accrued |
Countries
Argentina, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Israel, Russia, South Africa, Spain, Sweden, United Kingdom, United States
Outcome results
None listed