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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00737009
First received: August 15, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Identify predictors of non- adherence [ Time Frame: every 3- 6 months (4 visit in one year) ] [ Designated as safety issue: No ]
  • The proportion of DFS after 1 year follow-up [ Time Frame: every 3- 6 months (4 visit in one year) ] [ Designated as safety issue: No ]
  • Describe menopausal symptoms [ Time Frame: every 3- 6 months (4 visit in one year) ] [ Designated as safety issue: No ]

Enrollment: 259
Study Start Date: August 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737009

Locations
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hue, Vietnam
Sponsors and Collaborators
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 Hue Central Hospital
  More Information

No publications provided

Responsible Party: Luu, Thi Khanh Trang, Study Leader, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00737009     History of Changes
Other Study ID Numbers: NIS-OVN-ARI-2008/1
Study First Received: August 15, 2008
Last Updated: June 21, 2011
Health Authority: Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Breast cancer
adherence
anastrozole
post-menopausal women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013