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Completed

NCT Number: NCT00737009

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Hanoi, Vietnam

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Identify predictors of non- adherence

    Time frame: every 3- 6 months (4 visit in one year)

  3. The proportion of DFS after 1 year follow-up

    Time frame: every 3- 6 months (4 visit in one year)

  4. Describe menopausal symptoms

    Time frame: every 3- 6 months (4 visit in one year)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2008
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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