Status:
COMPLETED
Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT00332852
Start Date
March 1 2006
Last Update
February 23 2017
Active Locations (53)
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1
Novartis Investigative Site
Albstadt, Germany
2
Schorndorf
Augsburg, Germany
3
Novartis Investigative Site
Bamberg, Germany
4
Novartis Investigative Site
Berlin, Germany