Phase II Neoadjuvant in Inflammatory Breast Cancer

Inclusion criteria

• ✓. Have signed informed consent form (ICF) and a Patient Authorization Form (HIPAA).
• ✓. Histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass, involving the majority of the skin of the breast. Pathologic evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
• ✓. Tumors that overexpress ErbB2, defined as one of the following definitions: 3+ staining by immunohistochemistry and/or a FISH ratio of more than 2.2
• ✓. Have either measurable or clinically evaluable skin disease. Patients with metastasis but are candidates for mastectomy are eligible.
• ✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 1.
• ✓. Have left ventricular ejection fraction (LVEF) within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.
• ✓. Willing to under go 1 mandatory core biopsy (up to 4 passes) and 1 mandatory skin biopsy to confirm IBC diagnosis and for biologic expression profiling.Subjects with clinically palpable residual disease may undergo an optional 2nd and 3rd core needle biopsy (1 after initial 2-week Lapatinib therapy and 1 after 6 months of completing all chemotherapy, before surgery) to allow identification of presumed pathways of therapy resistance. Information may give subject options for other targeted therapies (e.g. trastuzumab) if definitive surgery confirms residual disease.
• ✓. Are able to swallow and retain oral medication (intact pill).

Exclusion criteria