Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant
* Drug: Anastrozole


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anastrozole | Drug: Anastrozole<br>* 1 mg oral tablet<br>* Other names: ZD1033;|
| Experimental: 2<br>Anastrozole + Fulvestrant | Drug: Fulvestrant<br>* intramuscular injection 250 mg loading dose (LD) regimen<br>* Other names: ZD9238;Drug: Anastrozole<br>* 1 mg oral tablet<br>* Other names: ZD1033;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) | RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments. | RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Evaluable Participants With Objective Response Rate (ORR) | No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions) | 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 | No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression) | RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 | 
| Duration of Response (DoR) | Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders | RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 | 
| Duration of Clinical Benefit (DoCB) | Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders | RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 | 
| Time to Treatment Failure (TTF) | Time from randomisation until the date of discontinuation of randomised treatment for any reason | From randomisation until data cut-off on 30th April 2009 | 
| Overall Survival (OS) | Overall survival is equivalent to time to death. Time from randomisation until the date of death | All deaths occurring between randomisation and data cut-off on 30th April 2009 are included. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone, receptor, positive, breast, cancer, first, relapse