Hormon Receptor Positive Breast CancerNCT01208779
Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
An observational study of Hormon Receptor Positive Breast Cancer, run by AstraZeneca at 2 sites in Serbia.
Trial summary
This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormon Receptor Positive Breast Cancer
- How many people
- 90 participants
- Where
- 2 sitesSerbia
- Study dates
- Jan 2011to Nov 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Oncology centers
Who may be able to join
- Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
- Provision of subject informed consent
Who cannot join
- If participating in any clinical trial, the subject cannot take part in this study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.
- Conditions
- Hormon Receptor Positive Breast Cancer
- Keywords
- Compliance, HR+ breast cancer, epidemiology
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
Measured: 12 months
Secondary outcomes (6)
Evaluate compliance rate, assessed by investigator, after 6 months of follow up
Measured: 12 months
Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months
Measured: 12 months
Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months
Measured: 12 months
Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status
Measured: 12 months
Primary disease (breast cancer) characteristics: receptor status, disease stage
Measured: 12 months
Disease management data: treatment/treatment changes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormon Receptor Positive 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
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Jasna Pesic, Principal investigator, M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208779
- Sponsor's protocol ID
- NIS-ORS-DUM-2010/1
- Status last verified
- Jul 2013
- First submitted
- 23 Sep 2010
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01208779
- Acronym / sponsor ID
- NIS-ORS-DUM-2010/1
- Conditions
- Hormon Receptor Positive Breast Cancer
- Keywords
- Compliance, HR+ breast cancer, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Sep 2010 (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 observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology centers
Key inclusion criteria (2 listed)
- Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
- Provision of subject informed consent
Key exclusion criteria (1 listed)
- If participating in any clinical trial, the subject cannot take part 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
Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
Time frame: 12 months
6 secondary outcomes
Evaluate compliance rate, assessed by investigator, after 6 months of follow up
Time frame: 12 months
Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months
Time frame: 12 months
Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months
Time frame: 12 months
Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status
Time frame: 12 months
Primary disease (breast cancer) characteristics: receptor status, disease stage
Time frame: 12 months
Disease management data: treatment/treatment changes
Time frame: 12 months
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 17 Jul 2013.
Related trials for Hormon Receptor Positive Breast Cancer
RecruitingObservational study
ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population
ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic)
Recruiting
Organ Culture for Endocrine Resistant Next Line: A Treatment Selection Study in Metastatic Breast Cancer
Metastatic Breast Cancer, Hormon Receptor Positive Breast Cancer
RecruitingPhase 2
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
Hormon Receptor Positive Breast Cancer, Breast Cancer
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.
Dr Jasna Pesic principal investigator
M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormon Receptor Positive Breast Cancer, run by AstraZeneca at 2 sites in Serbia.
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 2 inclusion and 1 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 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. 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?
Evaluate compliance rate, as assessed by investigator, after 12 months from baseline. (time frame: 12 months). 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 17 Jul 2013.