A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer...
Brief Summary
Official Title: “A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer”
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2008
Intervention(s) in this Clinical Trial
- Drug: fulvestrant
- 500 mg intramuscular injection
- Drug: anastrozole
- 1 mg oral tablet
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Fulvestrant
- Active Comparator: 2
- Anastrozole
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical Benefit Rate
- Time Frame: Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Eveluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.
Safety Issue?: No
- Time Frame: Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Eveluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.
Secondary Measures
- Objective Response Rate
- Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.
Safety Issue?: No
- Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.
- Time to Progression
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
- Duration of Response
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
- Duration of Clinical Benefit
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Confirmed hormone receptor positive advanced breast cancer, postmenopausal women
Exclusion Criteria:
- Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca Faslodex Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274469
Study ID Number: D6995C00006
ClinicalTrials.gov Identifier: NCT00274469
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00274469
