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

March 6, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Medical Oncology

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
Time Frame: During the study, at least annually
During the study, at least annually
Histological assessment when indicated(type of hyperplasia)
Time Frame: When applicable
When applicable
To assess global incidence of endometrial changes in this patient population before taking Anastrozole
Time Frame: During the study
During the study
To evaluate type of surgery required for endometrial changes control(hysterectomy rate)
Time Frame: During the study
During the study
To assess treatment tolerability
Time Frame: During the study
During the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Rosana Cajal, MD, AstraZeneca Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AST-ANA-2004-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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