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

AstraZeneca494 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

494

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (15)

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guangdong, China

Research Site

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: 24 months

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

Data from ClinicalTrials.gov

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