Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
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...
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.”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2009
Intervention(s) in this Clinical Trial
- Drug: Fulvestrant
- intramuscular injection 250 mg loading dose (LD) regimen
- 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 (TTP)
- Time Frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Secondary Measures
- Percentage of Evaluable Participants With Objective Response Rate (ORR)
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- Percentage of Clinical Benefit Rate (CBR) Responders
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- Duration of Response (DoR)
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- Duration of Clinical Benefit (DoCB)
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- Time to Treatment Failure (TTF)
- Time Frame: From randomisation until data cut-off on 30th April 2009
Safety Issue?: No
- Time Frame: From randomisation until data cut-off on 30th April 2009
- Overall Survival (OS)
- Time Frame: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Safety Issue?: No
- Time Frame: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor 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 Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Roger Henriksson, 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/NCT00256698
Study ID Number: D6997L00002
ClinicalTrials.gov Identifier: NCT00256698
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00256698
