- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562458
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer
February 4, 2013 updated by: AstraZeneca
ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)
To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
Study Overview
Study Type
Observational
Enrollment (Actual)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
Description
Inclusion Criteria:
- Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.
Exclusion Criteria:
- Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 21, 2007
First Posted (Estimate)
November 22, 2007
Study Record Updates
Last Update Posted (Estimate)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 4, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
Other Study ID Numbers
- NIS-ARO-HCH-2006/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on anastrozole
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The Affiliated Hospital of Qingdao UniversityUnknownBioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed ConditionHealthy VolunteersChina
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Xuanzhu Biopharmaceutical Co., Ltd.Not yet recruitingAdvanced Breast CancerChina
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Massachusetts General HospitalTerminatedKallmann Syndrome | Hypogonadotropic HypogonadismUnited States
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The Affiliated Hospital of Qingdao UniversityUnknown
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Ahon Pharmaceutical Co., Ltd.RecruitingAdvanced Breast Cancer | Female Breast CancerChina
-
Trans Tasman Radiation Oncology GroupActive, not recruitingBreast CancerAustralia, New Zealand
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Havah Therapeutics Pty LtdCompletedMammographic DensityAustralia
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Massachusetts General HospitalNational Institute on Aging (NIA)Completed
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Havah Therapeutics Pty LtdGTxCompletedMammographic DensityAustralia