Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Verified by: Novartis, March 2011
First Received: November 2, 2005 | Last Updated: March 15, 2011 | Phase: Phase 3 | Start Date: December 2005
Overall Status: Active, not recruiting | Estimated Enrollment: 4000
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Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates...

Brief Summary

Official Title: “Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer”

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2013

Intervention(s) in this Clinical Trial

  • Drug: Letrozole, anastrozole

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Letrozole
  • Active Comparator: Anastrozole

Outcome Measures for this Clinical Trial

Primary Measures

  • Compare rate of disease free survival at 5 years between letrozole and anastrozole
    • Time Frame: Disease-free survival 320 events and 639 events
      Safety Issue?: No

Secondary Measures

  • Compare the general safety between the two treatment arms
    • Time Frame: Disease-free survival 320 events and 639 events
      Safety Issue?: Yes
  • Compare the efficacy of the two treatment arms for overall survival
    • Time Frame: Disease-free survival 320 events and 639 events
      Safety Issue?: No
  • Compare the efficacy of the two treatment arms for time to development of distant metastases
    • Time Frame: Disease-free survival 320 events and 639 events
      Safety Issue?: No
  • Compare the efficacy of the two treatment arms for breast cancer specific survival
    • Time Frame: Disease-free survival 320 events and 639 events
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Recent primary surgery for breast cancer
  • Early stage breast cancer
  • Postmenopausal
  • Hormone receptor positive
  • Positive lymph node involvement

Exclusion Criteria:

  • Metastatic disease
  • Presence of contralateral breast cancer including DCIS
  • Progression
  • Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248170

Study ID Number: CFEM345D2411

ClinicalTrials.gov Identifier: NCT00248170

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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