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

February 13, 2014 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
      • Shenzhen, Guangdong, China
        • Research Site
    • Guizhou
      • Guiyang, Guizhou, China
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Research Site
    • Hunan
      • Changsha, Hunan, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Jilin
      • Changchun, Jilin, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Xi'an, Shanxi, China
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China
        • Research Site
    • Yunnan
      • Kunming, Yunnan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site
      • Ningbo, Zhejiang, China
        • Research Site
      • Wenzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6-18 months
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
6-18 months
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
6-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Karen Atkin, AstraZeneca
  • Principal Investigator: Prof. Shao Zhimin, Fudan University
  • Study Chair: Xu Johnson, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OCN-ARI-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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