Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
1 other identifier
observational
165
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2004
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 6, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMarch 9, 2009
March 1, 2009
February 6, 2008
March 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (1)
1
Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole
Eligibility Criteria
Medical Oncology
You may qualify if:
- 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.
You may not qualify if:
- Patients with evidence of metastatic disease
- Patients unsuitable to receive the medication according the Anastrozole label
- Patients not giving their Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
A Coruña, Spain
Research Site
Granada, Spain
Research Site
Huelva, Spain
Research Site
Ibiza Town, Spain
Research Site
Jerez de la Frontera, Spain
Research Site
La Rioja, Spain
Research Site
Lugo, Spain
Research Site
Mallorca, Spain
Research Site
Málaga, Spain
Research Site
Pontevedra, Spain
Research Site
Santander, Spain
Research Site
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rosana Cajal, MD
AstraZeneca Spain
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2008
First Posted
February 26, 2008
Study Start
June 1, 2004
Study Completion
February 1, 2009
Last Updated
March 9, 2009
Record last verified: 2009-03