Not Signed In -
Fulvestrant |
Faslodex |
Clinical Trial: A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
This study is not yet open for patient recruitment.
Verified by AstraZeneca December 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Metastatic Breast Cancer | Drug: fulvestrant Drug: anastrozole | Phase II |
MedlinePlus related topics: Breast Cancer; Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised, 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
Further study details as provided by AstraZeneca:
Primary Outcomes: The clinical benefit rate will be analysed when all patients have been in the study for 6 months.
Secondary Outcomes: Objective response, time to progression, duration of response, duration of clinical benefit and safety will be analysed when all patients have been in the study for 6 months. Response to subsequent therapy and tumour marker levels will also be analysed.
Expected Total Enrollment: 200
Secondary Outcomes: Objective response, time to progression, duration of response, duration of clinical benefit and safety will be analysed when all patients have been in the study for 6 months. Response to subsequent therapy and tumour marker levels will also be analysed.
Expected Total Enrollment: 200
Study start: January 2006
Eligibility
Genders Eligible for Study: Female
Criteria
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).
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00274469
AstraZeneca Study Information http://www.astrazeneca.com/node/emailtriage.aspx
Bulgaria
Research Site, Blagoevgrad, Bulgaria
Research Site, Pleven, Bulgaria
Research Site, Plovdiv, Bulgaria
Research Site, Russe, Bulgaria
Research Site, Shumen, Bulgaria
Research Site, Sofia, Bulgaria
Research Site, Varna, Bulgaria
Research Site, Veliko Tarnovo, Bulgaria
Czech Republic
Research Site, Brno, Czech Republic
Research Site, Chomutov, Czech Republic
Research Site, Ostrava, Czech Republic
Research Site, Praha 4, Czech Republic
Research Site, Usti nad Labem, Czech Republic
Spain, Andalucia
Research Site, Cordoba, Andalucia, Spain
Spain, Cataluna
Research Site, Barcelona, Cataluna, Spain
Research Site, Lerida, Cataluna, Spain
Spain, Galicia
Research Site, Pontevedra, Galicia, Spain
Research Site, Santiago de Compostela, Galicia, Spain
United Kingdom
Research Site, Dundee, United Kingdom
Research Site, Edinburgh, United Kingdom
Research Site, Nottingham, United Kingdom
Study chairs or principal investigators
AstraZeneca Faslodex Medical Science Director, MD, Study Director, AstraZeneca
More Information
Study ID Numbers: D6995C00006; FIRST
Last Updated: January 10, 2006
Record first received: January 10, 2006
ClinicalTrials.gov Identifier: NCT00274469
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Last Updated: January 10, 2006
Record first received: January 10, 2006
ClinicalTrials.gov Identifier: NCT00274469
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Resources
- Faslodex (Drug Digest)
- Faslodex Consumer Information (U.S. Food and Drug Administration)
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