Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Global incidence of endometrial changes during the adjuvant treatment with Anastrozole

Outcome 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.

Safety Issue:

No

Principal Investigator

Rosana Cajal, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca Spain

Authority:

Spain: Spanish Agency of Medicines

Study ID:

AST-ANA-2004-01

NCT ID:

NCT00623519

Start Date:

June 2004

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • Adjuvant postmenopausal breast cancer women
  • Breast Neoplasms
  • Adenoma

Name

Location