Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Chugai Pharmaceutical
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).

• 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.