Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

• Status: Completed
• Trial end date: 2009-01-21
• Target enrollment: 0
• Participant gender: All

Summary

Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Letrozole

Criteria

Inclusion Criteria:

1. Postmenopausal women

2. Primary locally invasive breast cancer

3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.

4. Post menopausal status

5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria:

1. Prior treatment with letrozole or tamoxifen.

2. Patients with bilateral breast tumors

3. Patients who are eligible for breast conserving surgery

4. Evidence of inflammatory breast cancer or distant metastasis.

5. Other concurrent malignant disease

6. Concomitant anti-cancer treatments such as chemotherapy

Other protocol-defined exclusion criteria may apply.