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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.


Phase 3
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


- 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

DFS

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

Greece: National Organization of Medicines

Study ID:

971-ONC-0028-085

NCT ID:

NCT00810706

Start Date:

April 2001

Completion Date:

November 2005

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Aromatase inhibitors
  • Exemestane
  • Tamoxifen
  • Lipids
  • Breast Neoplasms

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