An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737009
• Other study ID #: NIS-OVN-ARI-2008/1
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: June 21, 2011
• Start date: August 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh City
Vietnam	Research Site	Hue

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Identify predictors of non- adherence		every 3- 6 months (4 visit in one year)	No
Secondary	The proportion of DFS after 1 year follow-up		every 3- 6 months (4 visit in one year)	No
Secondary	Describe menopausal symptoms		every 3- 6 months (4 visit in one year)	No