Adjuvant Post-Tamoxifen Exemestane Trial

Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00810706
• Other study ID #: 971-ONC-0028-085
• Status: Terminated
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: December 16, 2008
• Start date: April 2001
• Est. completion date: November 2005

Study information

• Verified date: December 2008
• Source: Hellenic Breast Surgeons Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 448
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Greece	Hellenic Breast Surgeons Society	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Breast Surgeons Society

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS		5 years	No
Secondary	effect of exemestane on lipaemic profile		2 years	Yes