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NSABP B-42: Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

This study is open to patients who have had breast cancer with a positive estrogen and/or progesterone (ER/PgR) hormone receptor test and have already received five years of hormonal therapy to help prevent their cancer from returning.

The purpose of this study is to determine whether or not continuing hormonal therapy with letrozole, an aromatase inhibitor (AI) for five additional years after already taking five years of hormonal therapy can further reduce the chance of breast cancer recurring.

Letrozole is approved for use during the first five years after treatment for ER/PgR positive breast cancer. As used in this study, Letrozole is considered 'investigational' because it is not approved by the Food and Drug Administration (FDA) for use after five years of hormonal therapy. In this study, patients will be randomized to either Letrozole or a Placebo (a pill that looks like Letrozole but does not contain any active drug). Novartis Pharmaceuticals Corporation, through the National Cancer Institute will provide Letrozole/Placebo at no cost for this study.

Who is eligible to participate?

Some of the main eligibility criteria include:

  • Post-menopausal women with Stage I, Stage II, or Stage IIIA primary breast cancer
  • Estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) tumor
  • Received five years of hormonal therapy (AI for full five years or combination of up to three years of Tamoxifen followed by an AI)
  • No more than six months since finishing hormone therapy

Health professionals conducting the clinical trial will determine final eligibility.

For more information, please contact John Muir Clinical Research Center at clinicalresearch@johnmuirhealth.com.