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