Current Research: Medical Oncology

B-42 -- Letrozole vs Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an AI, or Tamoxifen Followed by an AI, in Prolonging Disease-Free Survival in HR+ Breast Cancer.

The main purpose of the study is to learn whether or not continuing hormonal therapy with an aromatase inhibitor (AI) called letrozole for 5 additional years after patients have already received 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning.

Letrozole is investigational for use in patients who have already received an AI as part of their 5 years of hormonal therapy.

Eligibility

You may be eligible for this trial if:

• You are female and postmenopausal
• You are disease-free from the time of initial breast cancer diagnosis until the time of randomization
• Your primary tumor was pathologic or clinical stage I, II, or IIIA invasive carcinoma of the breast documented by core needle or open biopsy.
• Your primary tumor was ER-positive and/or PgR-positive
• You have undergone either a lumpectomy with axillary nodal staging followed by breast radiotherapy or a total mastectomy with axillary nodal staging.
• It is within 6 months following completion of 5 years (57-63 months) of your initial adjuvant hormonal therapy.

Trial Sponsor

• National Surgical Adjuvant Breast and Bowel Project (NSABP)

Project Begin Date

• Mar 2007

Tentative Project End Date

• Dec 2011

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Revised April 14, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .