Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer

Inclusion criteria: * Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter * ER and/or PgR positive cancer (\> 10% of positive cancer cell assessed by IHC) * Postmenopausal status, defined by at least one of the following: ≥ 60 years of age \< 60 years of age and amenorrheic for ≥ 12 months prior to day 1 \< 60 years of age and amenorrheic for \< 12 months prior to day, or without a uterus: luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months * HER2 negative tumors (IHC 0-2+, or FISH negative) * Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment * Age over 18 years * ECOG PS 0-1 * Normal organ and marrow function as defined below: leukocytes \> 3000/mL absolute neutrophil count \> 1,500/mL platelets \> 100,000/mL total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT)\< 2.5 X institutional upper limit of normal Creatinine within normal institutional limits * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. * Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A …