Trial Information
A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Prof. Shao Zhimin
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fudan University
Authority:
China: Food and Drug Administration
Study ID:
NIS-OCN-ARI-2010/1
NCT ID:
NCT01144572
Start Date:
July 2010
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms