Clinical trial NCT01561443: LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
Official title: LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Advanced or Metastatic Postmenopausal Breast Cancer
Keywords: Breast cancer,
hormone positive,
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 153
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hormone positive, postmenopausal breast cancer

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

Eligibility criteria: 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

Primary outcomes:
measure: Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit
timeFrame: 2 years
measure: The extent of reduction anxiety inventory
timeFrame: 2 years
measure: Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease
timeFrame: 2 years
measure: Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment
timeFrame: 2 years
measure: Response duration
timeFrame: 2 years
measure: Performance status (ECOG)
timeFrame: 2 years
measure: Co-morbidities and relevant historical data
timeFrame: 2 years
measure: The information on spontaneous office visit to oncologist or hospitalization including reasons, diagnosis, days of hospitalization, procedures and concomitant medication changes will be collected.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chita
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: S-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov, Prof.
role: STUDY_DIRECTOR
affiliation: Russian Oncology Scientific Center
name: Maria Konstantinova, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Oncology Scientific Center
name: Sergey Gutorov, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgery Institute named after A.V. Vishnevskiy
name: Marina Stenina, PhD
role: PRINCIPAL_INVESTIGATOR
References: