Clinical trial NCT01399086: Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer
Official title: A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Cancer
Breast
Metastatic
Hormonotherapy
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 that fulfil the following-mentioned eligibility criteria and have initiated therapy with fuvestrant 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

Brief 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?

Eligibility criteria: 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

Primary outcomes:
measure: Time to Progression
timeFrame: 1 year
Secondary outcomes:
measure: Objective Response Rate
timeFrame: > 6 months
measure: Tumor growth control
timeFrame: >6 months
Other outcomes:
Locations:
city: Chania
country: Greece
facility: "Ag.Georgios" General Hospital of Chania
state: Crete
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "Agios Savvas" Anticancer Hospital of Athens
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Dep of Medical Oncology
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: