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

Phase 3
33 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Compare rate of disease free survival at 5 years between letrozole and anastrozole

Outcome Time Frame:

Disease-free survival 320 events and 639 events

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • letrozole
  • anastrozole
  • adjuvant
  • postmenopausal
  • FACE
  • Breast Neoplasms



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