Clinical trial NCT00737009: An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment
Official title: An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
adherence
anastrozole
post-menopausal women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 259
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
timeFrame: every 3- 6 months (4 visit in one year)
Secondary outcomes:
measure: Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up
timeFrame: every 3- 6 months (4 visit in one year)
measure: Identify predictors of non- adherence
timeFrame: every 3- 6 months (4 visit in one year)
measure: The proportion of DFS after 1 year follow-up
timeFrame: every 3- 6 months (4 visit in one year)
measure: Describe menopausal symptoms
timeFrame: every 3- 6 months (4 visit in one year)
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
affiliation: K Hospital Hanoi, Vietnam
name: Nguyen Van Dinh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCMC Cancer Hospital
name: Tran Nguyen Ha
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanoi Cancer Hospital
name: Tran Dang Khoa
role: PRINCIPAL_INVESTIGATOR
affiliation: Hue Central Hospital
name: Ton That Cau
role: PRINCIPAL_INVESTIGATOR
References: