Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

NCT ID: NCT01399086

Last Updated: 2012-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

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?

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fulvestrant

Fulvestrant

Intervention Type DRUG

250mg on d1,15,29 or 250mg on d1 q28days

Interventions

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Fulvestrant

250mg on d1,15,29 or 250mg on d1 q28days

Intervention Type DRUG

Other Intervention Names

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Faslodex

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Oncology Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vassilis Georgoulias, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

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"Ag.Georgios" General Hospital of Chania

Chania, Crete, Greece

Site Status

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Site Status

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

Site Status

"Agios Savvas" Anticancer Hospital of Athens

Athens, , Greece

Site Status

401 Military Hospital of Athens

Athens, , Greece

Site Status

Air Forces Military Hospital of Athens

Athens, , Greece

Site Status

IASO General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

Site Status

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, , Greece

Site Status

Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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CT/10.10

Identifier Type: -

Identifier Source: org_study_id

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