An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Phase: N/A
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Nguyen Van Dinh, MD, Principal Investigator, Affiliation: K Hospital Hanoi, Vietnam
Tran Nguyen Ha, Principal Investigator, Affiliation: HCMC Cancer Hospital
Tran Dang Khoa, Principal Investigator, Affiliation: Hanoi Cancer Hospital
Ton That Cau, Principal Investigator, Affiliation: Hue Central Hospital
Overall contact:
AstraZeneca Clinical Study, Information, Phone: 84-8-8278088, Email: nguyendiemquyen.le@astrazeneca.com
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.
Clinical Details
Official title: An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.
Study design: Time Perspective: Prospective
Primary outcome: To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
Secondary outcome: Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-upIdentify predictors of non- adherence The proportion of DFS after 1 year follow-up Describe menopausal symptoms
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Recurrence of breast cancer
- Known hypersensitivity to anastrozole or to any of its excipients
- Any severe concomitant condition which makes it undesirable for the patient to
participate in the trial or which would jeopardize adherence with the trial protocol:
Amenorrhea<12 months and a intact uterus; Previous inclusion in the present study;
Participation in a other clinical study during the last 30 days·
- Women who does not agreed to participate the program
Locations and Contacts
AstraZeneca Clinical Study, Information, Phone: 84-8-8278088, Email: nguyendiemquyen.le@astrazeneca.com
Research Site, Hanoi, Vietnam; Recruiting
Research Site, Ho Chi Minh City, Vietnam; Recruiting
Research Site, Hue, Vietnam; Recruiting
Additional Information
Starting date: August 2008
Last updated: July 8, 2009
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