Clinical trial NCT01144572: Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 494
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
timeFrame: 24 months
Secondary outcomes:
measure: The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months
timeFrame: 6-18 months
measure: 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
timeFrame: 6-18 months
measure: 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.
timeFrame: 6-18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Guiyang
country: China
facility: Research Site
state: Guizhou
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Ningbo
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Prof. Shao Zhimin
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Xu Johnson
role: STUDY_CHAIR
References:
citation: 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.