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

AstraZeneca

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00623519

AST-ANA-2004-01

Details and patient eligibility

About

To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.

Enrollment: 165 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

165 participants in 1 patient group

1

Description:

Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole