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

AstraZeneca

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00769080

NIS-OCN-ARI-2008/1

Details and patient eligibility

About

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

Enrollment: 524 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

524 participants in 2 patient groups

1

Description:

Standard Treatment plus PSP

2

Description:

Standard Treatment