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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01144572
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Study Start: 2010-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 494

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.	24 months

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Wenzhou, Zhejiang, China