The Performance of Patient Support Program in Early Stage Breast Cancer

NCT ID: NCT00769080

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Keywords

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PSP Standard Treatment Standard Treatment plus PSP

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Standard Treatment plus PSP

No interventions assigned to this group

2

Standard Treatment

No interventions assigned to this group

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Atkin

Role: STUDY_DIRECTOR

AstraZeneca

Emily Huang

Role: STUDY_CHAIR

AstraZeneca

Shen Zhenzhou, Prof

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Chongqing, Chongqing Municipality, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Nanning, Guangxi, China

Site Status

Research Site

Harbin, Heilongjiang, China

Site Status

Research Site

Wuhan, Hubei, China

Site Status

Research Site

Changsha, Hunan, China

Site Status

Research Site

Nanjing, Jiangsu, China

Site Status

Research Site

Qingdao, Shandong, China

Site Status

Research Site

Shanghai, Shanghai Municipality, China

Site Status

Research Site

Chengdu, Sichuan, China

Site Status

Research Site

Tianjin, Tianjin Municipality, China

Site Status

Research Site

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 22527106 (View on PubMed)

Other Identifiers

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NIS-OCN-ARI-2008/1

Identifier Type: -

Identifier Source: org_study_id