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An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Inclusion Criteria

Inclusion criteria:

- Compliant postmenopausal women with primary operable breast cancer after complete
surgery and suitable for endocrine treatment

- Nodal status negative or positive

- Good Health status 0-2 (Eastern Cooperative Oncology Group)

- Estrogen- and/or progesterone-receptor positive

- Adequate marrow, kidney and liver function

Exclusion criteria:

- Metastatic or inflammatory breast cancer

- Patients with previous or concomitant cancers (not breast cancer) within the past 5
years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer
of the cervix. Patients with other previous cancers must have been disease-free for
at least 5 years and Patients with uncontrolled, non-malignant systemic
cardiovascular, kidney, and liver diseases.

- Current/active dental problems including infection of the teeth or jawbone, dental or
fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of
exposed bone in the mouth, or of slow healing after dental procedures.

- Recent (within 6 weeks) or planned dental or jaw surgery

- Patients with primary overactive parathyroid

- Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging

Outcome Time Frame:

after 24 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Postive breast cancer
  • postmenopausal
  • disease free survival
  • letrozole
  • early adjuvant treatment
  • primary hormone receptor
  • Breast Neoplasms