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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623519
First Posted: February 26, 2008
Last Update Posted: March 9, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • To describe the endometrial changes both clinically(vaginal bleeding) and through the scan. [ Time Frame: During the study, at least annually ]
  • Histological assessment when indicated(type of hyperplasia) [ Time Frame: When applicable ]
  • To assess global incidence of endometrial changes in this patient population before taking Anastrozole [ Time Frame: During the study ]
  • To evaluate type of surgery required for endometrial changes control(hysterectomy rate) [ Time Frame: During the study ]
  • To assess treatment tolerability [ Time Frame: During the study ]

Enrollment: 165
Study Start Date: June 2004
Study Completion Date: February 2009
Groups/Cohorts
1
Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00623519


Locations
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, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rosana Cajal, MD AstraZeneca Spain
  More Information

Responsible Party: Rosana Cajal, MD - Medical Director, AstraZeneca Spain
ClinicalTrials.gov Identifier: NCT00623519     History of Changes
Other Study ID Numbers: AST-ANA-2004-01
First Submitted: February 6, 2008
First Posted: February 26, 2008
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
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
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