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

AstraZeneca

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01144572

NIS-OCN-ARI-2010/1

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

494 participants in 1 patient group

1

Description:

Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment