Adjuvant Post-Tamoxifen Exemestane Trial

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810706

Acronym

ATENA

Enrollment

448

Registered

2008-12-18

Start date

2001-04-30

Completion date

2005-11-30

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Aromatase inhibitors, Exemestane, Tamoxifen, Lipids

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.

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.

Interventions

DRUGexemestane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
DFS	5 years

Secondary

Measure	Time frame
effect of exemestane on lipaemic profile	2 years

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026