The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer...
Date First Received: November 20, 2005
Last Updated: September 4, 2008
Verified by: AstraZeneca, September 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 512
Brief Summary
Official Title: “FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Fulvestrant
- intramuscular injection
- Drug: Anastrozole
- 1 mg oral tablet
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Anastrozole
- Experimental: 2
- Anastrozole + Fulvestrant
Outcome Measures for this Clinical Trial
Primary Measures
- Time to progression
Secondary Measures
- Objective tumour response
- clinical benefit, safety
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or PgR positive breast cancer, local recurrence or metastasis
Exclusion Criteria:
- Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
- Premenopausal women
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 Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Roger Henriksson, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00256698
Study ID Number: D6997L00002
ClinicalTrials.gov Identifier: NCT00256698
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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