Status:
COMPLETED
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- Patients with evidence of metastatic disease
- Patients unsuitable to receive the medication according the Anastrozole label
- Patients not giving their Informed Consent
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00623519
Start Date
June 1 2004
End Date
February 1 2009
Last Update
March 9 2009
Active Locations (12)
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1
Research Site
A Coruña, Spain
2
Research Site
Granada, Spain
3
Research Site
Huelva, Spain
4
Research Site
Ibiza Town, Spain