TKI258 for Metastatic Inflammatory Breast Cancer Patients

Inclusion Criteria

• Patients have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on 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. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
• Patients have stage IV disease with local or distant relapse
• Patients have negative HER2 expression by IHC (defined as 0 or1+), or fluorescence in situ hybridization (FISH). If HER2 is 2+, negative HER2 expression must be confirmed by FISH.
• Patients are able to swallow and retain oral medication.
• Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patients have received two or more standard chemotherapies for metastatic disease and have relapsed.
• Patients have ability and willingness to sign written informed consent.
• Patients are 18 years of age or older.
• Female patients of childbearing potential (A female not free from menses > 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device. Highly effective contraception must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
• Female patients of childbearing potential must have negative serum pregnancy test 4 weeks.
• Patients have biopsy tissue of the metastatic disease (including chest wall or regional nodes) available (paraffin blocks or up to 20 unstained slides), if no biopsy tissue available, a biopsy (or thoracentesis if patient has pleural effusion only) of the metastatic disease will be performed to confirm the diagnoses.
• Serum total bilirubin must be within Upper Limited Normal (T. Bilirubin upper limit of normal (ULN)=1.0 mg/dl)
• AST and ALT must be 150 and/or a diastolic blood pressure (DBP)>100 mm Hg with or without anti-hypertensive medication.
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.
• Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients safety.
• Patients with only locally or regionally confined disease without evidence of metastatic disease.