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

This study is currently recruiting participants.
Verified April 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01561443
First received: March 19, 2012
Last updated: April 7, 2014
Last verified: April 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 ]

Estimated Enrollment: 205
Study Start Date: May 2012
Estimated Study Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561443

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com

Locations
Russian Federation
Research Site Recruiting
Chita, Russian Federation
Research Site Not yet recruiting
Irkutsk, Russian Federation
Research Site Not yet recruiting
Kaluga, Russian Federation
Research Site Not yet recruiting
Kazan, Russian Federation
Research Site Not yet recruiting
Kemerovo, Russian Federation
Research Site Not yet recruiting
Khanty-Mansiysk, Russian Federation
Research Site Not yet recruiting
Krasnodar, Russian Federation
Research Site Not yet recruiting
Krasnoyarsk, Russian Federation
Research Site Not yet recruiting
Moscow, Russian Federation
Research Site Not yet recruiting
Omsk, Russian Federation
Research Site Not yet recruiting
Perm, Russian Federation
Research Site Not yet recruiting
S-Petersburg, Russian Federation
Research Site Not yet recruiting
Samara, Russian Federation
Research Site Not yet recruiting
Tula, Russian Federation
Research Site Not yet recruiting
Tver, Russian Federation
Research Site Not yet recruiting
Ufa, Russian Federation
Research Site Not yet recruiting
Vladivostok, Russian Federation
Research Site Not yet recruiting
Volgograd, Russian Federation
Research Site Not yet recruiting
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: April 7, 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 April 17, 2014