- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784940
ATAC - Bone Density Sub-Protocol
April 24, 2009 updated by: AstraZeneca
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Phase 3
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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Eligible for entry into the main ATAC trial 1033IL/0029
- Women defined as post-menopausal
- Patients with histologically proven operable invasive breast cancer
- Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated
Exclusion Criteria:
- Excluded from entry into the main ATAC trial (1033IL/0029)
- Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
- Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
- Patients who have had a bone fracture within the previous 6 months prior to randomisation
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
|
1mg, orally, once daily
Other Names:
|
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
|
1mg, orally, once daily
Other Names:
20mg, orally, once daily
Other Names:
|
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
|
20mg, orally, once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to recurrence
|
Time to withdrawal
|
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
June 1, 1998
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
November 3, 2008
First Submitted That Met QC Criteria
November 3, 2008
First Posted (Estimate)
November 4, 2008
Study Record Updates
Last Update Posted (Estimate)
April 27, 2009
Last Update Submitted That Met QC Criteria
April 24, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
- Anastrozole
Other Study ID Numbers
- 1033ID/0029
- D5392C01985
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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