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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00737009

Enrollment

259

Registered

2008-08-18

Start date

2008-08-31

Completion date

2011-03-31

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, adherence, anastrozole, post-menopausal women

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

Vietnam

Outcome results