Breast CancerARI NISNCT00769080
The Performance of Patient Support Program in Early Stage Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 13 sites in China.
Trial summary
The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 524 participants
- Where
- 13 sitesChina
- Study dates
- Sep 2008to Oct 2010
- 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: Postmenopausal women with hormone sensitive early breast cancers to whom have been prescribed upfront adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The upfront AI medication must not have exceeded eight weeks.
Who may be able to join
- Provide signed and dated written Informed Consent
- Have been taking upfront AI adjuvant therapy in line with current SmPC
- Be capable of completing drug intake by herself
- Be capable of understanding Chinese
Who cannot join
- Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
- Upfront adjuvant AI medication which has exceeded over eight weeks
- Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Harbin, Heilongjiang
Research Site
Nanjing, Jiangsu
Research Site
Nanning, Guangxi
Research Site
Qingdao, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
About this study
Official title: A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year
- Conditions
- Breast Cancer
- Keywords
- PSP, Standard Treatment, Standard Treatment plus PSP
- Medical subject headings
- Breast Neoplasms
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 | Standard Treatment plus PSP | |
| 2 | Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the 1-year adherence
Measured: 1 year
Secondary outcomes (3)
scores of Beliefs about Medicines Questionnaire (BMQ)
Measured: 1 year
Scores in Patient Centred Care Questionnaire (PCCQ)
Measured: 1 year
Morisky scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Atkin, Study director, AstraZenecaEmily Huang, Study chair, AstraZenecaShen Zhenzhou, Prof, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769080
- Sponsor's protocol ID
- NIS-OCN-ARI-2008/1
- Acronym
- ARI NIS
- Status last verified
- Nov 2011
- First submitted
- 6 Oct 2008
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12.
PubMed 22527106
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00769080
- Acronym / sponsor ID
- ARI NIS / NIS-OCN-ARI-2008/1
- Conditions
- Breast Cancer
- Keywords
- PSP, Standard Treatment, Standard Treatment plus PSP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Oct 2008 (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 purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Standard Treatment plus PSP |
| 2 | – | –Standard Treatment |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women with hormone sensitive early breast cancers to whom have been prescribed upfront adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The upfront AI medication must not have exceeded eight weeks.
Key inclusion criteria (4 listed)
- Provide signed and dated written Informed Consent
- Have been taking upfront AI adjuvant therapy in line with current SmPC
- Be capable of completing drug intake by herself
- Be capable of understanding Chinese
Key exclusion criteria (4 listed)
- Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
- Upfront adjuvant AI medication which has exceeded over eight weeks
- Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
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
compare the 1-year adherence
Time frame: 1 year
3 secondary outcomes
scores of Beliefs about Medicines Questionnaire (BMQ)
Time frame: 1 year
Scores in Patient Centred Care Questionnaire (PCCQ)
Time frame: 1 year
Morisky scale
Time frame: 1 year
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 29 Nov 2011.
- Derived from this study: PubMed 22527106Yu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12.
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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.
Karen Atkin study director
AstraZeneca
Emily Huang study chair
AstraZeneca
Shen Zhenzhou, Prof principal investigator
Fudan University
13 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 13 sites in China.
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 4 inclusion and 4 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 29 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 13 sites in China. 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?
compare the 1-year adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769080, which also lists 1 linked publication.
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 29 Nov 2011; AzTrials last refreshed its copy on 2 Nov 2026.