Trial record 1 of 1 for:
NIS-OCN-ARI-2010/1
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment (BC Qol NIS)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01144572
First received: June 14, 2010
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
|
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.
Criteria
Inclusion Criteria:
- Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
- Undergoing upfront AIs adjuvant treatment within 7 days.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144572
Locations
| China, Beijing | |
| Research Site | |
| Beijing, Beijing, China | |
| China, Guangdong | |
| Research Site | |
| Guangzhou, Guangdong, China | |
| Research Site | |
| Shenzhen, Guangdong, China | |
| China, Guizhou | |
| Research Site | |
| Guiyang, Guizhou, China | |
| China, Heilongjiang | |
| Research Site | |
| Harbin, Heilongjiang, China | |
| China, Hunan | |
| Research Site | |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| Research Site | |
| Nanjing, Jiangsu, China | |
| China, Jilin | |
| Research Site | |
| Changchun, Jilin, China | |
| China, Shanghai | |
| Research Site | |
| Shanghai, Shanghai, China | |
| China, Shanxi | |
| Research Site | |
| Xi'an, Shanxi, China | |
| China, Tianjin | |
| Research Site | |
| Tianjin, Tianjin, China | |
| China, Yunnan | |
| Research Site | |
| Kunming, Yunnan, China | |
| China, Zhejiang | |
| Research Site | |
| Hangzhou, Zhejiang, China | |
| Research Site | |
| Ningbo, Zhejiang, China | |
| Research Site | |
| Wenzhou, Zhejiang, China | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Prof. Shao Zhimin | Fudan University |
| Study Director: | Karen Atkin | AstraZeneca |
| Study Chair: | Xu Johnson | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01144572 History of Changes |
| Other Study ID Numbers: | NIS-OCN-ARI-2010/1 |
| Study First Received: | June 14, 2010 |
| Last Updated: | April 9, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic |
Aromatase Inhibitors Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013