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CompletedNCT00769080ARI NISUpdated Nov 29, 2011

The Performance of Patient Support Program in Early Stage Breast Cancer

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 13 sites in China. Open to female participants. Per ClinicalTrials.gov, last updated 2011-11-29.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
524
Sex
Female
01

Study summary

The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year

02

Conditions studied

  • Breast Cancer

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Keywords

  • PSP
  • Standard Treatment
  • Standard Treatment plus PSP
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 524 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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Postmenopausal women with hormone sensitive early breast cancers to whom have been prescribed upfront adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The upfront AI medication must not have exceeded eight weeks.

Inclusion criteria

  • Provide signed and dated written Informed Consent
  • Have been taking upfront AI adjuvant therapy in line with current SmPC
  • Be capable of completing drug intake by herself
  • Be capable of understanding Chinese

Exclusion criteria

Exclusion Criteria:

  • Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
  • Upfront adjuvant AI medication which has exceeded over eight weeks
  • Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
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Study design

Time perspective
Prospective
Enrollment
524 participants (actual)

Groups and cohorts

  • 1

    Standard Treatment plus PSP

  • 2

    Standard Treatment

06

What researchers measure

Primary outcomes

  1. compare the 1-year adherence

    Time frame: 1 year

Secondary outcomes

  1. scores of Beliefs about Medicines Questionnaire (BMQ)

    Time frame: 1 year

  2. Scores in Patient Centred Care Questionnaire (PCCQ)

    Time frame: 1 year

  3. Morisky scale

    Time frame: 1 year

07

Study locations

13 sites
  • Research Site
    Beijing, Beijing, China
  • Research Site
    Chongqing, Chongqing, China
  • Research Site
    Guangzhou, Guangdong, China
  • Research Site
    Nanning, Guangxi, China
  • Research Site
    Harbin, Heilongjiang, China
  • Research Site
    Wuhan, Hubei, China
  • Research Site
    Changsha, Hunan, China
  • Research Site
    Nanjing, Jiangsu, China
  • Research Site
    Qingdao, Shandong, China
  • Research Site
    Shanghai, Shanghai, China
  • Research Site
    Chengdu, Sichuan, China
  • Research Site
    Tianjin, Tianjin, China
  • Research Site
    Hangzhou, Zhejiang, China
08

References and documents

Publications

  • Yu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12. PubMed 22527106 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00769080
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Oct 8, 2008
Start date
Sep 2008
Completion
Oct 2010
Last update
Nov 29, 2011

Study contacts

Karen Atkin
study director · AstraZeneca
Emily Huang
study chair · AstraZeneca
Shen Zhenzhou, Prof
principal investigator · Fudan University

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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