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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | 250mg on d1,15,29 or 250mg on d1 q28days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 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 | > 6 months |
| Tumor growth control |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Ag.Georgios" General Hospital of Chania | Chania | Crete | Greece | |||
| University Hospital of Crete, Dep of Medical Oncology |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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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
| >6 months |
| Heraklion |
| Crete |
| Greece |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | Alexandroupoli | Greece |
| "Agios Savvas" Anticancer Hospital of Athens | Athens | Greece |
| 401 Military Hospital of Athens | Athens | Greece |
| Air Forces Military Hospital of Athens | Athens | Greece |
| IASO General Hospital of Athens, 1st Dep of Medical Oncology | Athens | Greece |
| State General Hospital of Larissa, Dep of Medical Oncology | Larissa | Greece |
| Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Thessaloniki | Greece |
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |