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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
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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:

Interventional

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:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CFEM345DDE10

NCT ID:

NCT00332852

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

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