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

January 8, 2016 updated by: AstraZeneca
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).

Study Overview

Status

Completed

Conditions

Detailed Description

LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

hormone positive, postmenopausal breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (ESTIMATE)

March 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ORU-XXX-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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