Local Advanced or Metastatic Postmenopausal Breast CancerLINENCT01561443
LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
An observational study of Local Advanced or Metastatic Postmenopausal Breast Cancer, run by AstraZeneca at 19 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Local Advanced or Metastatic Postmenopausal Breast Cancer
- How many people
- 153 participants
- Where
- 19 sitesRussia
- Study dates
- May 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: hormone positive, postmenopausal breast cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Research Site
Chita
Research Site
Irkutsk
Research Site
Kaluga
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Khanty-Mansiysk
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Omsk
Research Site
Perm
Research Site
S-Petersburg
Research Site
Samara
Research Site
Tula
Research Site
Tver'
Research Site
Ufa
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Yaroslavl
About this study
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).
Read the detailed description
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
- Keywords
- Breast cancer,, hormone positive,
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer
Measured: 2 years
Secondary outcomes (8)
Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit
Measured: 2 years
The extent of reduction anxiety inventory
Measured: 2 years
Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease
Measured: 2 years
Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment
Measured: 2 years
Response duration
Measured: 2 years
Performance status (ECOG)
Measured: 2 years
Co-morbidities and relevant historical data
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Advanced or Metastatic Postmenopausal Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Prof., Study director, AstraZenecaMaria Konstantinova, Prof, Principal investigator, Russian Oncology Scientific CenterSergey Gutorov, Prof., Principal investigator, Russian Oncology Scientific CenterMarina Stenina, PhD, Principal investigator, Surgery Institute named after A.V. Vishnevskiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561443
- Sponsor's protocol ID
- NIS-ORU-XXX-2011/1
- Acronym
- LINE
- Status last verified
- Jan 2016
- First submitted
- 19 Mar 2012
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01561443
- Acronym / sponsor ID
- LINE / NIS-ORU-XXX-2011/1
- Keywords
- Breast cancer,, hormone positive,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hormone positive, postmenopausal breast cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit
Time frame: 2 years
The extent of reduction anxiety inventory
Time frame: 2 years
Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease
Time frame: 2 years
Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment
Time frame: 2 years
Response duration
Time frame: 2 years
Performance status (ECOG)
Time frame: 2 years
Co-morbidities and relevant historical data
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Clinical study report synopsisLink provided by the sponsor.
- CSR\_synopis\_NIS-ORU-XXX-2011/1Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Stepanov, Prof. study director
AstraZeneca
Maria Konstantinova, Prof principal investigator
Russian Oncology Scientific Center
Sergey Gutorov, Prof. principal investigator
Russian Oncology Scientific Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Advanced or Metastatic Postmenopausal Breast Cancer, run by AstraZeneca at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.