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

AstraZeneca165 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

165

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

A Coruña, Spain

Research Site

Granada, Spain

Research Site

Huelva, Spain

Research Site

Ibiza Town, Spain

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.

Time frame: During the study, at least annually

Histological assessment when indicated(type of hyperplasia)

Time frame: When applicable

To assess global incidence of endometrial changes in this patient population before taking Anastrozole

Time frame: During the study

To evaluate type of surgery required for endometrial changes control(hysterectomy rate)

Time frame: During the study

To assess treatment tolerability

Time frame: During the study

Data from ClinicalTrials.gov

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