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This is the first study focused on features/stereotypes of the first and second-line treatment patterns in Russia, comparison of different treatments, and determination of effective hormone treatment patterns in real-life practice with evaluation of pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical effectiveness of second-line hormone treatment and quality of life in patients with breast cancer(BC).
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit | 2 years | |
| The extent of reduction anxiety inventory | 2 years | |
| Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease |
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Inclusion Criteria:
Exclusion Criteria:
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hormone positive, postmenopausal breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Alexey Stepanov, Prof. | AstraZeneca | Study Director |
| Maria Konstantinova, Prof | Russian Oncology Scientific Center | Principal Investigator |
| Sergey Gutorov, Prof. | Russian Oncology Scientific Center | Principal Investigator |
| Marina Stenina, PhD | Surgery Institute named after A.V. Vishnevskiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chita | Russia | ||||
| Research Site |
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| Label | URL |
|---|---|
| Clinical study report synopsis | View source |
| CSR\_synopis\_NIS-ORU-XXX-2011/1 | View source |
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| 2 years |
| Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment | 2 years |
| Response duration | 2 years |
| Performance status (ECOG) | 2 years |
| Co-morbidities and relevant historical data | 2 years |
| The information on spontaneous office visit to oncologist or hospitalization including reasons, diagnosis, days of hospitalization, procedures and concomitant medication changes will be collected. | 2 years |
| Irkutsk |
| Russia |
| Research Site | Kaluga | Russia |
| Research Site | Kazan' | Russia |
| Research Site | Kemerovo | Russia |
| Research Site | Khanty-Mansiysk | Russia |
| Research Site | Krasnodar | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Omsk | Russia |
| Research Site | Perm | Russia |
| Research Site | S-Petersburg | Russia |
| Research Site | Samara | Russia |
| Research Site | Tula | Russia |
| Research Site | Tver' | Russia |
| Research Site | Ufa | Russia |
| Research Site | Vladivostok | Russia |
| Research Site | Volgograd | Russia |
| Research Site | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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