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Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Closed

18 and over

Pharmaceutical / Industry

CFEM345EBR01
NCT00237133

Trial Description

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)

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00237133
Information obtained from ClinicalTrials.gov on August 28, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.