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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00623519
First received: February 6, 2008
Last updated: March 6, 2009
Last verified: March 2009
  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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the endometrial changes both clinically(vaginal bleeding) and through the scan. [ Time Frame: During the study, at least annually ] [ Designated as safety issue: No ]
  • Histological assessment when indicated(type of hyperplasia) [ Time Frame: When applicable ] [ Designated as safety issue: No ]
  • To assess global incidence of endometrial changes in this patient population before taking Anastrozole [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • To evaluate type of surgery required for endometrial changes control(hysterectomy rate) [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • To assess treatment tolerability [ Time Frame: During the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rosana Cajal, MD - Medical Director, AstraZeneca Spain
ClinicalTrials.gov Identifier: NCT00623519     History of Changes
Other Study ID Numbers: AST-ANA-2004-01
Study First Received: February 6, 2008
Last Updated: March 6, 2009
Health Authority: Spain: Spanish Agency of Medicines

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
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014