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Completed

NCT Number: NCT01561443

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

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).

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Key information

Conditions

Local Advanced or Metastatic Postmenopausal Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Chita, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit

    Time frame: 2 years

  2. The extent of reduction anxiety inventory

    Time frame: 2 years

  3. Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease

    Time frame: 2 years

  4. Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment

    Time frame: 2 years

  5. Response duration

    Time frame: 2 years

  6. Performance status (ECOG)

    Time frame: 2 years

  7. Co-morbidities and relevant historical data

    Time frame: 2 years

  8. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: LINE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2012
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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