Local Advanced or Metastatic Postmenopausal Breast Cancer Clinical Trial
— LINEOfficial title:
LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
| Verified date | January 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ethics Committee |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Postmenopausal women with hormone receptor-positive breast cancer: - Recurrence after the adjuvant hormone therapy; - Or initially inoperable locally advanced or metastatic breast cancer progressed after the first line hormone therapy; - Ability to read and write and complete questionnaires Provision of written informed consent - Patients who have already been prescribed therapy with the above-mentioned lines and who can continue on the prescribed therapy in the investigator's opinion according to his/her regular clinical practice and cure Exclusion Criteria: - As per study design, to ensure high validity of data and to obtain accurate information on real-life practice, - Patients currently participating in other clinical studies will not be included in this study |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Site | Chita | |
| Russian Federation | Research Site | Irkutsk | |
| Russian Federation | Research Site | Kaluga | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Khanty-Mansiysk | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Krasnoyarsk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | S-Petersburg | |
| Russian Federation | Research Site | Samara | |
| Russian Federation | Research Site | Tula | |
| Russian Federation | Research Site | Tver | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Vladivostok | |
| Russian Federation | Research Site | Volgograd | |
| Russian Federation | Research Site | Yaroslavl |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer | 2 years | No | |
| Secondary | Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit | 2 years | No | |
| Secondary | The extent of reduction anxiety inventory | 2 years | No | |
| Secondary | Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease | 2 years | No | |
| Secondary | Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment | 2 years | No | |
| Secondary | Response duration | 2 years | No | |
| Secondary | Performance status (ECOG) | 2 years | No | |
| Secondary | Co-morbidities and relevant historical data | 2 years | No | |
| Secondary | 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 | No |