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CompletedNCT01144572BC Qol NISUpdated Feb 14, 2014

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

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 15 sites in China. Open to female participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-02-14.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
494
Ages
50 Years to 70 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Breast Cancer

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Keywords

  • 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
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 494 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
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.

Inclusion criteria

  • Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
  • Undergoing upfront AIs adjuvant treatment within 7 days.

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
494 participants (actual)

Groups and cohorts

  • 1

    Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment

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What researchers measure

Primary outcomes

  1. The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

15 sites
  • Research Site
    Beijing, Beijing, China
  • Research Site
    Guangzhou, Guangdong, China
  • Research Site
    Shenzhen, Guangdong, China
  • Research Site
    Guiyang, Guizhou, China
  • Research Site
    Harbin, Heilongjiang, China
  • Research Site
    Changsha, Hunan, China
  • Research Site
    Nanjing, Jiangsu, China
  • Research Site
    Changchun, Jilin, China
  • Research Site
    Shanghai, Shanghai, China
  • Research Site
    Xi'an, Shanxi, China
  • Research Site
    Tianjin, Tianjin, China
  • Research Site
    Kunming, Yunnan, China
  • Research Site
    Hangzhou, Zhejiang, China
  • Research Site
    Ningbo, Zhejiang, China
  • Research Site
    Wenzhou, Zhejiang, China
08

References and documents

Publications

  • Cao A, Zhang J, Liu X, Wu W, Liu Y, Fan Z, Zhang A, Zhou T, Fu P, Wang S, Ouyang Q, Tang J, Jiang H, Zhang X, Pang D, He J, Shi L, Wang X, Sheng Y, Mao D, Shao Z. Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study. Health Qual Life Outcomes. 2016 Mar 24;14:51. doi: 10.1186/s12955-016-0446-2. PubMed 27009092 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01144572
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 15, 2010
Start date
Jul 2010
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Feb 14, 2014

Study contacts

Prof. Shao Zhimin
principal investigator · Fudan University
Karen Atkin
study director · AstraZeneca
Xu Johnson
study chair · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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