- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810706
Adjuvant Post-Tamoxifen Exemestane Trial (ATENA)
December 16, 2008 updated by: Hellenic Breast Surgeons Society
A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.
The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5 years of adjuvant exemestane versus 5 years of observation in postmenopausal women with operable breast cancer who have received 5-7 years of adjuvant tamoxifen.
The primary endpoint for the core protocol is disease-free survival (DFS).
Exemestane treatment is planned for 5 years unless disease relapse or excessive toxicity is documented, the patient refuses further treatment or any new anti-cancer therapy is initiated.
Study Overview
Detailed Description
- Patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry.
- A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment.
Study Type
Interventional
Enrollment (Actual)
448
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece, 11527
- Hellenic Breast Surgeons Society
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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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- postmenopausal women only
- histologically confirmed stage I-IIIA primary adenocarcinoma of the breast
- estrogen and/or progesterone receptors positive or unknown
- patients should have undergone surgery with a curative intent
- patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry
- Absence of any evidence of local or distant metastatic disease was required prior to randomization
Exclusion Criteria:
- DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 1: observation only
Patients have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day).
Tamoxifen could have been discontinued up to 6 months prior to study entry.
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Active Comparator: 2: Exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
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Patients randomised to receive exemestane (25 mg/day) for 5 years.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DFS
Time Frame: 5 years
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5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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effect of exemestane on lipaemic profile
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Markopoulos C, Chrissochou M, Michailidou A, Tzoracoleftherakis E, Xepapadakis G, Papadiamantis J, Misitzis J, Zobolas V, Bafaloukos D, Gogas H. Effect of exemestane on the lipidemic profile of post-menopausal operable breast cancer patients following 5-7 years of adjuvant tamoxifen: preliminary results of the ATENA substudy. Anticancer Drugs. 2005 Sep;16(8):879-83. doi: 10.1097/01.cad.0000173478.12981.e1.
- Markopoulos C, Chrissochou M, Antonopoulou Z, Xepapadakis G, Papadiamantis J, Tzoracoleftherakis E, Gogas H. Duration of tamoxifen effect on lipidemic profile of postmenopausal breast cancer patients following deprivation of treatment. Oncology. 2006;70(4):301-5. doi: 10.1159/000096251. Epub 2006 Oct 12.
- Markopoulos C, Dafni U, Misitzis J, Zobolas V, Tzoracoleftherakis E, Koukouras D, Xepapadakis G, Papadiamantis J, Venizelos B, Antonopoulou Z, Gogas H. Extended adjuvant hormonal therapy with exemestane has no detrimental effect on the lipid profile of postmenopausal breast cancer patients: final results of the ATENA lipid substudy. Breast Cancer Res. 2009;11(3):R35. doi: 10.1186/bcr2320. Epub 2009 Jun 16.
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
April 1, 2001
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 18, 2008
Study Record Updates
Last Update Posted (Estimate)
December 18, 2008
Last Update Submitted That Met QC Criteria
December 16, 2008
Last Verified
December 1, 2008
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
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Exemestane
Other Study ID Numbers
- 971-ONC-0028-085
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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