NCT01144572

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

June 14, 2010

Last Update Submit

February 13, 2014

Conditions

Breast Cancer

Keywords

Quality of Lifepostmenopausal HR(+)Early Breast Canceradjuvant AI treatmentQuality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (3)

  • The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 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

    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.

    6-18 months

Study Arms (1)

1

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

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Shenzhen, Guangdong, China

Location

Research Site

Guiyang, Guizhou, China

Location

Research Site

Harbin, Heilongjiang, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Research Site

Kunming, Yunnan, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Ningbo, Zhejiang, China

Location

Research Site

Wenzhou, Zhejiang, China

Location

Related Publications (1)

  • 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.

    PMID: 27009092DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Shao Zhimin

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Karen Atkin

    AstraZeneca

    STUDY DIRECTOR

  • Xu Johnson

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

CN(15)