NCT01399086

Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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?

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant	250mg on d1,15,29 or 250mg on d1 q28days

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-07-21
• Last updated: 2012-03-13

Locations

9 sites across 1 country: Greece