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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:
Information provided by:
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT00810706
First received: December 16, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hellenic Breast Surgeons Society:

Primary Outcome Measures:
  • DFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect of exemestane on lipaemic profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810706

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

Publications:

Additional 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
Study First Received: December 16, 2008
Last Updated: December 16, 2008
Health Authority: Greece: National Organization of Medicines

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
Adjuvants, Immunologic
Tamoxifen
Exemestane
Aromatase Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013