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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623519
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : March 9, 2009
Information provided by:

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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 165 participants
Time Perspective: Prospective
Official Title: Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
Study Start Date : June 2004
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole
U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical Oncology

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623519

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, Spain
Sponsors and Collaborators
Study Director: Rosana Cajal, MD AstraZeneca Spain

Responsible Party: Rosana Cajal, MD - Medical Director, AstraZeneca Spain Identifier: NCT00623519     History of Changes
Other Study ID Numbers: AST-ANA-2004-01
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Adjuvant postmenopausal breast cancer women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs