NCT00623519CompletedNot Applicable
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (1)
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