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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01144572
First received: June 14, 2010
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 494
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144572

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
Research Site
Shenzhen, Guangdong, China
China, Guizhou
Research Site
Guiyang, Guizhou, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China, Yunnan
Research Site
Kunming, Yunnan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Research Site
Ningbo, Zhejiang, China
Research Site
Wenzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof. Shao Zhimin Fudan University
Study Director: Karen Atkin AstraZeneca
Study Chair: Xu Johnson AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01144572     History of Changes
Other Study ID Numbers: NIS-OCN-ARI-2010/1
Study First Received: June 14, 2010
Last Updated: February 13, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014