Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Breast Cancer Clinical Trial

— BC Qol NIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144572
• Other study ID #: NIS-OCN-ARI-2010/1
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: February 13, 2014
• Start date: July 2010
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Hunan
China	Research Site	Guangzhou	Guangdong
China	Research Site	Guiyang	Guizhou
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Harbin	Heilongjiang
China	Research Site	Kunming	Yunnan
China	Research Site	Nanjing	Jiangsu
China	Research Site	Ningbo	Zhejiang
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenzhen	Guangdong
China	Research Site	Tianjin	Tianjin
China	Research Site	Wenzhou	Zhejiang
China	Research Site	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.		24 months	No
Secondary	The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months		6-18 months	No
Secondary	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		6-18 months	No
Secondary	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.		6-18 months	No