Breast CancerARIADNENCT01081509
Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence
An observational study of Breast Cancer, run by AstraZeneca at 25 sites in Hungary.
Trial summary
The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,077 participants
- Where
- 25 sitesHungary
- Study dates
- Mar 2010to Oct 2011
- 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: Early breast cancer patients on adjuvant aromatase inhibitor
Who may be able to join
- Early breast cancer
- Post menopausal
- Adjuvant hormonal Arimidex therapy
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Hungary25 sites
Research Site
Balatonföldvár
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Debrecen
Research Site
Dombóvár
Research Site
Gyöngyös
Research Site
Győr
Research Site
Gyula
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Mosdós
Research Site
Nagyatád
Research Site
Nyíregyháza
Research Site
Orfű
Research Site
Pápa
Research Site
Pécs
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szentes
Research Site
Szombathely
Research Site
Veszprém
Research Site
Zalaegerszeg
Research Site
Zirc
About this study
Official title: Survey and Follow-up of the Treatment Adherence and Medication Habits of Early Breast Cancer Patients on Adjuvant Hormonal Therapy With the Aromatase Inhibitor Arimidex
The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.
- Conditions
- Breast Cancer
- Keywords
- adherence, early breast cancer, Arimidex, Therapy adherence
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients remaining adherent to therapy with Arimidex
Measured: Every 3 months
Secondary outcomes (1)
Questionnaire for factors influencing adherence
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zsolt Horvath, M.D., Ph.D., Principal investigator, Hungarian National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081509
- Sponsor's protocol ID
- NIS-OHU-ARI-2010/1
- Acronym
- ARIADNE
- Status last verified
- Nov 2011
- First submitted
- 4 Mar 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey and Follow-up of the Treatment Adherence and Medication Habits of Early Breast Cancer Patients on Adjuvant Hormonal Therapy With the Aromatase Inhibitor Arimidex
- ClinicalTrials.gov ID
- NCT01081509
- Acronym / sponsor ID
- ARIADNE / NIS-OHU-ARI-2010/1
- Conditions
- Breast Cancer
- Keywords
- adherence, early breast cancer, Arimidex, Therapy adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Mar 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.
The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.
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
- Early breast cancer patients on adjuvant aromatase inhibitor
Key inclusion criteria (3 listed)
- Early breast cancer
- Post menopausal
- Adjuvant hormonal Arimidex therapy
Key exclusion criteria (0 listed)
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
Percent of patients remaining adherent to therapy with Arimidex
Time frame: Every 3 months
1 secondary outcome
Questionnaire for factors influencing adherence
Time frame: Every 3 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 16 Nov 2011.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zsolt Horvath, M.D., Ph.D. principal investigator
Hungarian National Institute of Oncology
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 25 sites in Hungary.
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 3 inclusion and 0 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Hungary. 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?
Percent of patients remaining adherent to therapy with Arimidex (time frame: Every 3 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 16 Nov 2011.