|Inclusion Criteria:||1) The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment, for the procurement of tumor samples by a core biopsy procedure prior to randomization, and for submission of tumor and blood samples required for the FB-7 correlative science studies|
2) Patients must be female.
3) Patients must be >/= 18 years old.
4) The ECOG performance status must be 0 or 1
5) Patients must have the ability to swallow oral medication
6) The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.
7) Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)
8) Breast cancer must be determined to be HER2-positive prior to randomization. Assays using Fluorescence In Situ Hybridization (FISH) or Cytokine-inducible SH2-containing protein (CISH) require gene amplification. Assays using IHC require a strongly positive (3+) staining score
9) Clinical staging, based on the assessment by physical exam, must be AJCC stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1; cT3 and CN0 or cN1; Any cT and cN2 or cN3; or cT4
10) The patient must have a mass in the breast or axilla measuring >/= 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required
11) At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: ANC must be >/= 1200/mm3, Platelet count must be >/= 100,000/mm3, Hemoglobin must be >/= 10 g/dL
12) The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be </= ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be </= 2.5 x ULN for the lab and AST and ALT must be </= 1.5 x ULN for the lab.
13) Patients with alkaline phosphatase > ULN but </= 2.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in #12 are met.
14) Patients with either unexplained skeletal pain or alkaline phosphatase that is > ULN but </= 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.
15) Serum creatinine performed within 4 weeks prior to randomization must be </= 1.5 x ULN for the lab.
16) The LVEF assessment by 2-D echocardiogram or MUGA scan performed within 90 days prior to randomization must be >/= 50% regardless of the facility's LLN. Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if targeted therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is >/=70%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.