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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623519
• Other study ID #: AST-ANA-2004-01
• Status: Completed
• Phase: N/A
• First received: February 6, 2008
• Last updated: March 6, 2009
• Start date: June 2004
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Spain	Research Site	Coruña
Spain	Research Site	Granada
Spain	Research Site	Huelva
Spain	Research Site	Ibiza
Spain	Research Site	Jerez
Spain	Research Site	La Rioja
Spain	Research Site	Lugo
Spain	Research Site	Malaga
Spain	Research Site	Mallorca
Spain	Research Site	Pontevedra
Spain	Research Site	Santander
Spain	Research Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global incidence of endometrial changes during the adjuvant treatment with Anastrozole		From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.	No
Secondary	To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.		During the study, at least annually	No
Secondary	Histological assessment when indicated(type of hyperplasia)		When applicable	No
Secondary	To assess global incidence of endometrial changes in this patient population before taking Anastrozole		During the study	No
Secondary	To evaluate type of surgery required for endometrial changes control(hysterectomy rate)		During the study	No
Secondary	To assess treatment tolerability		During the study	No