Adjuvant Post-Tamoxifen Exemestane Trial

NCT00810706 | Terminated Phase 3

• 1 other identifier: 971-ONC-0028-085
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Aromatase inhibitors; Exemestane; Tamoxifen; Lipids

Outcome Measures

Primary Outcomes (1)

• DFS

  5 years

Secondary Outcomes (1)

• effect of exemestane on lipaemic profile

  2 years

Study Arms (2)

1: observation only

NO INTERVENTION

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.

2: Exemestane

ACTIVE COMPARATOR

Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment

Drug: exemestane

Interventions

exemestane DRUG

Patients randomised to receive exemestane (25 mg/day) for 5 years.

Also known as: Aromasin

2: Exemestane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative

Sponsors & Collaborators

• Hellenic Breast Surgeons Society: lead

Study Sites (1)

Hellenic Breast Surgeons Society

Athens, 11527, Greece

Location

Related Publications (3)

• 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.

  PMID: 16096437 RESULT

• 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.

  PMID: 17047401 RESULT

• 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.

  PMID: 19531217 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: April 1, 2001
• Study Completion: November 1, 2005
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

GR (1)