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OpenTrials
Completed

NCT Number: NCT00623519

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.

    Time frame: During the study, at least annually

  2. Histological assessment when indicated(type of hyperplasia)

    Time frame: When applicable

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

    Time frame: During the study

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

    Time frame: During the study

  5. To assess treatment tolerability

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2009
First posted
Feb 26, 2008
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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