An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment
1 other identifier
observational
259
1 country
3
Brief Summary
The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2008
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 22, 2011
June 1, 2011
2.6 years
August 15, 2008
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
every 3- 6 months (4 visit in one year)
Secondary Outcomes (4)
Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up
every 3- 6 months (4 visit in one year)
Identify predictors of non- adherence
every 3- 6 months (4 visit in one year)
The proportion of DFS after 1 year follow-up
every 3- 6 months (4 visit in one year)
Describe menopausal symptoms
every 3- 6 months (4 visit in one year)
Eligibility Criteria
The target study population comprised of postmenopausal women with early breast cancer who were treated with anastrozole for at least one month and are willing to give written informed consent to participate.
You may qualify if:
- Postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice.
- Histologically or cytologically proven to be HR+(ER or PR +)
- No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
- Provision of written informed consent
You may not qualify if:
- Recurrence of breast cancer
- Known hypersensitivity to anastrozole or to any of its excipients
- Women who does not agreed to participate the program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Huế, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nguyen Van Dinh, MD
K Hospital Hanoi, Vietnam
- PRINCIPAL INVESTIGATOR
Tran Nguyen Ha
HCMC Cancer Hospital
- PRINCIPAL INVESTIGATOR
Tran Dang Khoa
Hanoi Cancer Hospital
- PRINCIPAL INVESTIGATOR
Ton That Cau
Hue Central Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 18, 2008
Study Start
August 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 22, 2011
Record last verified: 2011-06