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Clinical Trials/NCT00623519
NCT00623519CompletedNot Applicable

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

AstraZeneca1 site in 1 country165 target enrollmentStarted: June 2004Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
165
Locations
1
Primary Endpoint
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole

Study Overview

Brief 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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

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.(During the study, at least annually)
  • Histological assessment when indicated(type of hyperplasia)(When applicable)
  • To assess global incidence of endometrial changes in this patient population before taking Anastrozole(During the study)
  • To evaluate type of surgery required for endometrial changes control(hysterectomy rate)(During the study)
  • To assess treatment tolerability(During the study)

Investigators

Sponsor Class
Industry

Study Sites (1)

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