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CompletedNCT00623519Updated Mar 9, 2009

Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 12 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-09.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
165
Ages
18 Years and older
Sex
Female
01

Study summary

To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Adjuvant postmenopausal breast cancer women
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 165 is below 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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Medical Oncology

Inclusion criteria

  • Provision of Informed Consent
  • Resectable breast cancer patients, with histological confirmation
  • Patients eligible to receive hormonal adjuvant treatment with Anastrozole
  • They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
  • Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
  • Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level >40UI/L / women under 50 years with FSH levels>40UI/L).
  • Women showing progesterone and/or estrogen receptors positive.

Exclusion criteria

Exclusion Criteria:

  • Patients with evidence of metastatic disease
  • Patients unsuitable to receive the medication according the Anastrozole label
  • Patients not giving their Informed Consent
05

Study design

Time perspective
Prospective
Enrollment
165 participants (actual)

Groups and cohorts

  • 1

    Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole

06

What researchers measure

Primary outcomes

  1. Global incidence of endometrial changes during the adjuvant treatment with Anastrozole

    Time frame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.

Secondary outcomes

  1. To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.

    Time frame: During the study, at least annually

  2. Histological assessment when indicated(type of hyperplasia)

    Time frame: When applicable

  3. To assess global incidence of endometrial changes in this patient population before taking Anastrozole

    Time frame: During the study

  4. To evaluate type of surgery required for endometrial changes control(hysterectomy rate)

    Time frame: During the study

  5. To assess treatment tolerability

    Time frame: During the study

07

Study locations

12 sites
  • Research Site
    Coruña, Spain
  • Research Site
    Granada, Spain
  • Research Site
    Huelva, Spain
  • Research Site
    Ibiza, Spain
  • Research Site
    Jerez, Spain
  • Research Site
    La Rioja, Spain
  • Research Site
    Lugo, Spain
  • Research Site
    Malaga, Spain
  • Research Site
    Mallorca, Spain
  • Research Site
    Pontevedra, Spain
  • Research Site
    Santander, Spain
  • Research Site
    Sevilla, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00623519
Lead sponsor
AstraZeneca
First posted
Feb 26, 2008
Start date
Jun 2004
Completion
Feb 2009
Last update
Mar 9, 2009

Study contacts

Rosana Cajal, MD
study director · AstraZeneca Spain
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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