A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
N/A
N/A
Female
Breast Cancer
Trial Information
A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Inclusion Criteria:
- Breast Cancer has continued to grow after having received treatment with an
anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
- Evidence of positive estrogen receptor hormone sensitivity
- Written informed consent to participate in the trial
Exclusion Criteria:
- 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 (i.e. castor
oil)
- Treatment with more than one regimen of chemotherapy for advanced breast cancer
- Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to Progression (TTP)
Outcome Description:
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Outcome Time Frame:
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Safety Issue:
No
Principal Investigator
Faslodex Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D6997C00002
NCT ID:
NCT00099437
Start Date:
February 2005
Completion Date:
September 2013
Related Keywords:
- Breast Cancer
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Research Site | Mesa, Arizona |
| Research Site | Anaheim, California |
| Research Site | Danbury, Connecticut |
| Research Site | Boca Raton, Florida |
| Research Site | Arlington Heights, Illinois |
| Research Site | Baltimore, Maryland |
| Research Site | Battle Kreek, Michigan |
| Research Site | Branson, Missouri |
| Research Site | Belleville, New Jersey |
| Research Site | Abilene, Texas |
| Research Site | Appleton, Wisconsin |
