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CompletedNCT00737009Updated Jun 22, 2011

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

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 3 sites in Vietnam. Open to female participants. Per ClinicalTrials.gov, last updated 2011-06-22.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
259
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • adherence
  • anastrozole
  • post-menopausal women
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 259 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

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
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Study design

Time perspective
Prospective
Enrollment
259 participants (actual)
06

What researchers measure

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)

07

Study locations

3 sites
  • Research Site
    Hanoi, Vietnam
  • Research Site
    Ho Chi Minh City, Vietnam
  • Research Site
    Hue, Vietnam
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00737009
Lead sponsor
AstraZeneca
First posted
Aug 18, 2008
Start date
Aug 2008
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Jun 22, 2011

Study contacts

Nguyen Van Dinh, MD
principal investigator · K Hospital Hanoi, Vietnam
Tran Nguyen Ha
principal investigator · HCMC Cancer Hospital
Tran Dang Khoa
principal investigator · Hanoi Cancer Hospital
Ton That Cau
principal investigator · Hue Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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