Back to resultsAdjuvant Post-Tamoxifen Exemestane Trial (ATENA)
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Aromatase inhibitors, Exemestane, Tamoxifen, Lipids
Eligibility Criteria
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
Sites / Locations
- Hellenic Breast Surgeons Society
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1: observation only
2: Exemestane
Arm Description
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.
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
Outcomes
Primary Outcome Measures
DFS
Secondary Outcome Measures
effect of exemestane on lipaemic profile
Full Information
NCT ID
NCT00810706
First Posted
December 16, 2008
Last Updated
December 16, 2008
Sponsor
Hellenic Breast Surgeons Society
1. Study Identification
Unique Protocol Identification Number
NCT00810706
Brief Title
Adjuvant Post-Tamoxifen Exemestane Trial
Acronym
ATENA
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
Publication of MA17 results (similar trial in the extented adjuvant setting with letrozole)
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hellenic Breast Surgeons Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Aromatase inhibitors, Exemestane, Tamoxifen, Lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
448 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: observation only
Arm Type
No Intervention
Arm Description
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.
Arm Title
2: Exemestane
Arm Type
Active Comparator
Arm Description
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
Patients randomised to receive exemestane (25 mg/day) for 5 years.
Primary Outcome Measure Information:
Title
DFS
Time Frame
5 years
Secondary Outcome Measure Information:
Title
effect of exemestane on lipaemic profile
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hellenic Breast Surgeons Society
City
Athens
ZIP/Postal Code
11527
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
16096437
Citation
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.
Results Reference
result
PubMed Identifier
17047401
Citation
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.
Results Reference
result
PubMed Identifier
19531217
Citation
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.
Results Reference
derived
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Adjuvant Post-Tamoxifen Exemestane Trial
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