A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)
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?
Observational
Observational Model: Cohort, Time Perspective: Retrospective
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
No
Vassilis Georgoulias, MD
Principal Investigator
University Hospital of Crete, Dep of Medical Oncology
Greece: National Organization of Medicines
CT/10.10
NCT01399086
April 2011
September 2011
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