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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00623519
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-06
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole	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

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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Sevilla, Spain