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A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment


N/A
50 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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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

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