Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01399086|
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : March 13, 2012
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Fulvestrant|
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?
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
250mg on d1,15,29 or 250mg on d1 q28days
Other Name: Faslodex
- Time to Progression [ Time Frame: 1 year ]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
- Objective Response Rate [ Time Frame: > 6 months ]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
- Tumor growth control [ Time Frame: >6 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399086
|"Ag.Georgios" General Hospital of Chania|
|Chania, Crete, Greece|
|University Hospital of Crete, Dep of Medical Oncology|
|Heraklion, Crete, Greece|
|University General Hospital of Alexandroupolis, Dep of Medical Oncology|
|"Agios Savvas" Anticancer Hospital of Athens|
|401 Military Hospital of Athens|
|Air Forces Military Hospital of Athens|
|IASO General Hospital of Athens, 1st Dep of Medical Oncology|
|State General Hospital of Larissa, Dep of Medical Oncology|
|Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology|
|Principal Investigator:||Vassilis Georgoulias, MD||University Hospital of Crete, Dep of Medical Oncology|