Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
448 participants
INTERVENTIONAL
2001-04-30
2005-11-30
Brief Summary
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Detailed Description
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* A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
2: Exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years.
Interventions
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exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Hellenic Breast Surgeons Society
OTHER
Responsible Party
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Hellenic Breast Surgeons Society
Locations
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Hellenic Breast Surgeons Society
Athens, , Greece
Countries
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References
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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.
Other Identifiers
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971-ONC-0028-085
Identifier Type: -
Identifier Source: org_study_id