We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737009
First Posted: August 18, 2008
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


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) ]

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) ]
  • Identify predictors of non- adherence [ Time Frame: 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) ]
  • Describe menopausal symptoms [ Time Frame: every 3- 6 months (4 visit in one year) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: June 22, 2011
Last Verified: June 2011

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
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs