Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
- Patients with histologically documented breast cancer.
- Patients with hormone receptor (ER and/or PgR) status of positive or unknown
- Patients who have been amenorrheic for the preceding 12 months or more.
- Patients who are 20 years or older and younger than 75 years.
- Patients with a history of postoperative adjuvant therapy or a history of endocrine
therapy with tamoxifen for the treatment of progression or recurrence of the lesion.
The endocrine therapy, however, should not exceed one regimen.
- Patients with progressing lesions.
- Patients with sufficient organ function to evaluate the safety
- Patients whose performance status (PS) is classified in 0～2.
- Patients who have no residual effects from previous treatments
- Patients with other concurrent or previous malignant disease (excluding uterine
- Patients with hypercalcemia and uncontrollable cardiac disease (including a history
of serious cardiac disease)
- Patients who have previously received aromatase inhibitor.
- Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.
Other protocol-defined inclusion / exclusion criteria may apply.