Official Title: “An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.”

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.

Study Type: Observational

Study Design: Other, Prospective

Primary Measures

• To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
  • Time Frame: every 3- 6 months (4 visit in one year)
    Safety Issue?: No

Secondary Measures

• Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up
  • Time Frame: every 3- 6 months (4 visit in one year)
    Safety Issue?: No
• Identify predictors of non- adherence
  • Time Frame: every 3- 6 months (4 visit in one year)
    Safety Issue?: No
• The proportion of DFS after 1 year follow-up
  • Time Frame: every 3- 6 months (4 visit in one year)
    Safety Issue?: No
• Describe menopausal symptoms
  • Time Frame: every 3- 6 months (4 visit in one year)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Nguyen Van Dinh, MD Principal Investigator K Hospital Hanoi, Vietnam  

Overall Contact: AstraZeneca Clinical Study, Information 84-8-8278088 nguyendiemquyen.le@astrazeneca.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00737009

Study ID Number: NIS-OVN-ARI-2008/1

ClinicalTrials.gov Identifier: NCT00737009

Health Authority: Vietnam: Ministry of Health