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A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 (HER-2/neu) Overexpressing Breast Cancer (TEACH)

Time frame of study:		Ongoing
Location of Study:		Beth Israel Medical Center
Contact:		Continuum Cancer Center Research Program (212) 844-6286

Summary:
The purpose of this randomized, placebo-controlled trial is to evaluate lapatinib, a new adjuvant treatment for breast cancer, specifically for HER-2/neu-overexpressing breast cancer, which has a high risk of recurrence. While preliminary studies have shown that adding trastuzumab, a drug which is similar to lapatinib, to the adjuvant chemotherapy significantly reduces the risk of recurrence, no trials have tested this type of drug on women who have already completed chemotherapy without trastuzumab. This trial is a randomized trial to compare the patient’s current therapy with the addition of either lapatinib or a placebo.

Eligibility:
Women with early-stage HER-2/neu-overexpressing breast cancer who have not been previously treated with trastuzumab, have already completed primary adjuvant chemotherapy, and currently have no clinical or radiologic evidence of disease. Please call for more information.

Benefits and/or Compensation:
There is no monetary compensation for this study. The information gathered from this study may be beneficial to future patients, and lapatinib may reduce the risk of HER-2/neu-overexpressing breast cancer from recurring.