Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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This is a retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on patients who have commenced treatment with fulvestrant after January 1st of 2007. All necessary information for the purposes of the present study will be collected with the use of a paper-Case Record Form.

Detailed Description
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To date, there are no available data on the use of fulvestrant in the treatment of postmenopausal women with metastatic breast cancer in current clinical practice in Greece. In view of this significant lack of knowledge, we designed this retrospective study in order to evaluate the effectiveness of fulvestrant in real-life settings, by obtaining data regarding the use of fulvestrant in current clinical practice among treating physicians in Greece. This retrospective study aims to address the following questions: What is the clinical outcome of fulvestrant treatment in terms of TTP when used in metastatic breast cancer in a real life clinical setting? What is the positioning of fulvestrant in the hormone therapy sequencing in metastatic breast cancer in Greece? What are the other clinical outcomes (ORR, duration of response, CBR) of fulvestrant treatment in metastatic breast cancer in a real life clinical setting and what is the relation between clinical outcomes and fulvestrant's position in the treatment sequence? What is the usual duration of fulvestrant treatment in metastatic breast cancer in the real life clinical setting and which are the reasons for treatment discontinuation? Treatment failure with fulvestrant: what is the next step in sequencing according to patients' breast cancer treatment history?

Official Title
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A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with ER-positive and/or PgR-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease Patients who have received treatment with fulvestrant for metastatic breast cancer and have completed/discontinued the treatment regardless of outcome/reason for discontinuation (except for treatment discontinuation for non-clinical reasons) Patients who were at postmenopausal status at the time of treatment with fulvestrant Exclusion Criteria: Patients who are currently undergoing treatment with fulvestrant Investigators/treating physicians with no available electronical or paper-based medical records

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fulvestrant<br> | Drug: Fulvestrant<br>* 250mg on d1,15,29 or 250mg on d1 q28days<br>* Other names: Faslodex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression | To evaluate the time to progression (TTP) from the initiation of fulvestrant treatment in postmenopausal women with endocrine-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | To evaluate the objective response rate (ORR), i.e. the rate of both complete and partial response, and to estimate the duration of response while on treatment with fulvestrant | > 6 months | 
| Tumor growth control | To evaluate the clinical benefit rate (CBR), i.e. the rate of both complete and partial response as well as stable disease ≥ 6 months, while on treatment with fulvestrant, where applicable | >6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Breast, Metastatic, Hormonotherapy