The Performance of Patient Support Program in Early Stage Breast Cancer (ARI NIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769080
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : November 29, 2011
Information provided by (Responsible Party):

October 6, 2008
October 8, 2008
November 29, 2011
September 2008
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compare the 1-year adherence [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00769080 on Archive Site
  • scores of Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: 1 year ]
  • Scores in Patient Centred Care Questionnaire (PCCQ) [ Time Frame: 1 year ]
  • Morisky scale [ Time Frame: 1 year ]
Same as current
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The Performance of Patient Support Program in Early Stage Breast Cancer
A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
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
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Time Perspective: Prospective
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Non-Probability Sample
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.
Breast Cancer
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  • 1
    Standard Treatment plus PSP
  • 2
    Standard Treatment
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2010
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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:

  • 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)
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
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Study Director: Karen Atkin AstraZeneca
Study Chair: Emily Huang AstraZeneca
Principal Investigator: Shen Zhenzhou, Prof Fudan University
November 2011