LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01561443

Acronym

LINE

Enrollment

153

Registered

2012-03-23

Start date

2012-05-31

Completion date

2015-01-31

Last updated

2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Advanced or Metastatic Postmenopausal Breast Cancer

Keywords

Breast cancer,, hormone positive,

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
The extent of reduction anxiety inventory	2 years
Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease	2 years
Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment	2 years
Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit	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
Response duration	2 years

Countries

Russia

Outcome results