Skip to main content
Log in

Phase III ATENA Trial of Exemestane Discontinued

  • Trial Report
  • Published:
Pharmaceutical Medicine Aims and scope Submit manuscript

Abstract

ATENA (Adjuvant post-Tamoxifen Exemestane versus Nothing Applied): 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. The primary endpoint is disease-free survival. The effects of extended adjuvant therapy with exemestane on the lipid profile was a secondary endpoint. This trial was prematurely discontinued in November 2005 due to poor accrual following publication of the results of the MA.17 trial, which demonstrated a reduced risk of recurrence with extended adjuvant therapy using letrozole.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Table I
Table II
Table III
Table IV
Table V

Similar content being viewed by others

Notes

  1. This summary has been extracted from Clinical Trials Insight, a proprietary database owned by Adis. Clinical Trials Insight is a database of global drug trial information that aides in the identification and assessment of published results and ongoing clinical studies.

References

  1. Markopoulos C, et al. 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 Research 2009; 11 (3): R35

    Article  PubMed  Google Scholar 

  2. Goss PE, et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med 2003; 349 (19): 1793–802

    Article  PubMed  CAS  Google Scholar 

  3. Clinical Trials.gov. Breast cancer: exemestane [online]. Available from URL: http://clinicaltrials.gov/ct2/show/NCT00810706 [Accessed 2012 Jan 13]

  4. Novartis International AG. Femara gains approval in Switzerland as only post-tamoxifen treatment for early breast cancer [media release]. 2004 Aug 12 [online]. Available from URL: http://www.novartis.com [Accessed 2012 Jan 13]

    Google Scholar 

  5. Novartis Oncology. Femara® (letrozole tablets) gains U.S. FDA approval as only post-tamoxifen treatment for early breast cancer [media release]. 2004 Oct 29 [online]. Available from URL: http://www.novartis.com [Accessed 2012 Jan 13]

    Google Scholar 

  6. Novartis. Femara® approved in Germany as the only hormonal therapy given after standard tamoxifen for post-menopausal womenwith early breast cancer [media release]. 2005 Mar 7 [online]. Available from URL: http://www.novartis.com [Accessed 2012 Jan 13]

    Google Scholar 

  7. Novartis Pharmaceuticals Canada Inc. Health Canada approves first and only breast cancer treatment that improves disease-free survival beyond five years of diagnosis [media release]. 2005 Apr 11 [online]. Available from URL: http://www.novartis.ca [Accessed 2012 Jan 13]

    Google Scholar 

  8. di Salle E, et al. Exemestane (FCE 24304), a new steroidal aromatase inhibitor. J Steroid Biochem Mol Biol 1992; 43 (1–3): 137–43

    Article  PubMed  CAS  Google Scholar 

  9. Haynes BP, et al. The pharmacology of letrozole. J Steroid Biochem Mol Biol 2003; 87 (1): 35–45

    Article  PubMed  CAS  Google Scholar 

  10. Goss PE. Risks versus benefi ts in the clinical application of aromatase inhibitors. Endocr Relat Cancer 1999; 6 (2): 325–32

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Sweetlove, M. Phase III ATENA Trial of Exemestane Discontinued. Pharm Med 26, 45–47 (2012). https://doi.org/10.1007/BF03256891

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF03256891

Keywords

Navigation