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

June 21, 2011 updated by: AstraZeneca

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam
        • Research Site
      • Hue, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
every 3- 6 months (4 visit in one year)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
every 3- 6 months (4 visit in one year)
Identify predictors of non- adherence
Time Frame: every 3- 6 months (4 visit in one year)
every 3- 6 months (4 visit in one year)
The proportion of DFS after 1 year follow-up
Time Frame: every 3- 6 months (4 visit in one year)
every 3- 6 months (4 visit in one year)
Describe menopausal symptoms
Time Frame: every 3- 6 months (4 visit in one year)
every 3- 6 months (4 visit in one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Nguyen Van Dinh, MD, K Hospital Hanoi, Vietnam
  • Principal Investigator: Tran Nguyen Ha, HCMC Cancer Hospital
  • Principal Investigator: Tran Dang Khoa, Hanoi Cancer Hospital
  • Principal Investigator: Ton That Cau, Huế Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OVN-ARI-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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