LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01561443
First received: March 19, 2012
Last updated: March 4, 2013
Last verified: March 2013
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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: | February 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Detailed Description:
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
Eligibility| Ages Eligible for Study: | 45 Years and older |
| 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 | information.center@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: | March 4, 2013 |
| 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 May 16, 2013