LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
Completed
- Conditions
- Local Advanced or Metastatic Postmenopausal Breast Cancer
- Registration Number
- NCT01561443
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 153
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer 2 years
- Secondary Outcome Measures
Name Time Method Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit 2 years Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment 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 Performance status (ECOG) 2 years The extent of reduction anxiety inventory 2 years Response duration 2 years Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease 2 years
Trial Locations
- Locations (1)
Research Site
🇷🇺Yaroslavl, Russian Federation