Clinical trial · Observational
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
NCT00623519CI-TRIAL-00002115completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole
Primary outcomes (1)
- measure
- Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
- timeFrame
- 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)
- measure
- To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
- timeFrame
- During the study, at least annually
- measure
- Histological assessment when indicated(type of hyperplasia)
- timeFrame
- When applicable
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.