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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01561443
First received: March 19, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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).


Condition
Local Advanced or Metastatic Postmenopausal Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The extent of reduction anxiety inventory [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Performance status (ECOG) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Co-morbidities and relevant historical data [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hormone positive, postmenopausal breast cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561443

Locations
Russian Federation
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov, Prof. AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01561443     History of Changes
Other Study ID Numbers: NIS-ORU-XXX-2011/1
Study First Received: March 19, 2012
Last Updated: May 19, 2014
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
Breast cancer,
hormone positive,

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014