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Electronic Study for Anastrozole Pharmacovigilance Evaluation (E-SAFE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558168
First Posted: November 14, 2007
Last Update Posted: July 28, 2008
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
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer

Condition
Early Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Electronic Study for Anastrozole Pharmacovigilance Evaluation

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Enrollment: 1850
Study Start Date: January 2004
Study Completion Date: July 2008
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.

Exclusion Criteria:

  • Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
  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): NCT00558168


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Nejdet Uskent Kadir Has University Medical School
  More Information

ClinicalTrials.gov Identifier: NCT00558168     History of Changes
Other Study ID Numbers: ARI-IPEP-0104
First Submitted: November 13, 2007
First Posted: November 14, 2007
Last Update Posted: July 28, 2008
Last Verified: July 2008

Keywords provided by AstraZeneca:
Anastrazole
safety
early breast cancer

Additional relevant MeSH terms:
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