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Adjuvant Post-Tamoxifen Exemestane Trial (ATENA)

This study has been terminated.
(Publication of MA17 results (similar trial in the extented adjuvant setting with letrozole))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00810706
First Posted: December 18, 2008
Last Update Posted: December 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hellenic Breast Surgeons Society
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: exemestane Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hellenic Breast Surgeons Society:

Primary Outcome Measures:
  • DFS [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • effect of exemestane on lipaemic profile [ Time Frame: 2 years ]

Enrollment: 448
Study Start Date: April 2001
Study Completion Date: November 2005
Arms Assigned Interventions
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.
Active Comparator: 2: Exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
Drug: exemestane
Patients randomised to receive exemestane (25 mg/day) for 5 years.
Other Name: Aromasin

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810706


Locations
Greece
Hellenic Breast Surgeons Society
Athens, Greece, 11527
Sponsors and Collaborators
Hellenic Breast Surgeons Society
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markopoulos Christos, Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier: NCT00810706     History of Changes
Other Study ID Numbers: 971-ONC-0028-085
First Submitted: December 16, 2008
First Posted: December 18, 2008
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Hellenic Breast Surgeons Society:
Breast Cancer
Aromatase inhibitors
Exemestane
Tamoxifen
Lipids

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action