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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01144572
First received: June 14, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes

June 14, 2010
April 9, 2013
July 2010
June 2012   (final data collection date for primary outcome measure)
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01144572 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.
Breast Cancer
Not Provided
1
Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
June 2013
June 2012   (final data collection date for primary outcome measure)

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.
Female
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01144572
NIS-OCN-ARI-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Prof. Shao Zhimin Fudan University
Study Director: Karen Atkin AstraZeneca
Study Chair: Xu Johnson AstraZeneca
AstraZeneca
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP