Breast CancerBC Qol NISNCT01144572
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
An observational study of Breast Cancer, run by AstraZeneca at 15 sites in China.
Trial summary
The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 494 participants
- Where
- 15 sitesChina
- Study dates
- Jul 2010to Oct 2013
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.
Who may be able to join
- Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
- Undergoing upfront AIs adjuvant treatment within 7 days.
Who cannot join
- Patients who disagree to participate this study
- Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements.
- The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Guangzhou, Guangdong
Research Site
Guiyang, Guizhou
Research Site
Hangzhou, Zhejiang
Research Site
Harbin, Heilongjiang
Research Site
Kunming, Yunnan
Research Site
Nanjing, Jiangsu
Research Site
Ningbo, Zhejiang
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenzhen, Guangdong
Research Site
Tianjin, Tianjin Municipality
Research Site
Wenzhou, Zhejiang
Research Site
Xi’an, Shanxi
About this study
Official title: A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
- Conditions
- Breast Cancer
- Keywords
- Quality of Life, postmenopausal HR(+), Early Breast Cancer, adjuvant AI treatment, Quality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
- 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 | Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
Measured: 24 months
Secondary outcomes (3)
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months
Measured: 6-18 months
The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months
Measured: 6-18 months
The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months.
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Shao Zhimin, Principal investigator, Fudan UniversityKaren Atkin, Study director, AstraZenecaXu Johnson, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144572
- Sponsor's protocol ID
- NIS-OCN-ARI-2010/1
- Acronym
- BC Qol NIS
- Status last verified
- Feb 2014
- First submitted
- 14 Jun 2010
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cao A, Zhang J, Liu X, Wu W, Liu Y, Fan Z, Zhang A, Zhou T, Fu P, Wang S, Ouyang Q, Tang J, Jiang H, Zhang X, Pang D, He J, Shi L, Wang X, Sheng Y, Mao D, Shao Z. Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study. Health Qual Life Outcomes. 2016 Mar 24;14:51. doi: 10.1186/s12955-016-0446-2.
PubMed 27009092
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
- ClinicalTrials.gov ID
- NCT01144572
- Acronym / sponsor ID
- BC Qol NIS / NIS-OCN-ARI-2010/1
- Conditions
- Breast Cancer
- Keywords
- Quality of Life, postmenopausal HR(+), Early Breast Cancer, adjuvant AI treatment, Quality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jun 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 purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.
Key inclusion criteria (2 listed)
- Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
- Undergoing upfront AIs adjuvant treatment within 7 days.
Key exclusion criteria (3 listed)
- Patients who disagree to participate this study
- Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements.
- The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.
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
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
Time frame: 24 months
3 secondary outcomes
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months
Time frame: 6-18 months
The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months
Time frame: 6-18 months
The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months.
Time frame: 6-18 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 14 Feb 2014.
- Derived from this study: PubMed 27009092Cao A, Zhang J, Liu X, Wu W, Liu Y, Fan Z, Zhang A, Zhou T, Fu P, Wang S, Ouyang Q, Tang J, Jiang H, Zhang X, Pang D, He J, Shi L, Wang X, Sheng Y, Mao D, Shao Z. Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study. Health Qual Life Outcomes. 2016 Mar 24;14:51. doi: 10.1186/s12955-016-0446-2.
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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.
Prof. Shao Zhimin principal investigator
Fudan University
Karen Atkin study director
AstraZeneca
Xu Johnson study chair
AstraZeneca
15 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 15 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 2 inclusion and 3 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. (time frame: 24 months). 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 NCT01144572, 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 14 Feb 2014.