Patient description: The patient is a 45-year-old postmenopausal woman with cytologically confirmed breast cancer. A core biopsy revealed a 3 cm invasive ductal breast carcinoma in the left upper outer quadrant. The tumor is HER2-positive and ER/PR negative. Axillary sampling revealed 5 positive lymph nodes. CXR was remarkable for metastatic lesions. The patient is using multivitamins and iron supplements. She does not smoke or consume alcohol. She is not sexually active and has no children. She is a candidate for tumor resection and agrees to do so prior to chemotherapy.

Clinical trial eligibility criteria: eligible ages (years): 18.0-100.0,  Breast Cancer FOR PART A OF THE STUDY Women age greater than or equal to 18 years AJCC 7 clinical stage II or III breast cancer. Clarification: Participants with clinical stage II breast cancer who are later classified as histologically-confirmed stage I will remain on study; participants who are later classified as histologically-confirmed stage IV breast cancer will be taken off study Biopsy-accessible breast tumor or participant candidates for primary surgery Eastern Cooperative Oncology Group (ECOG) performance status 0 1  Prior history of non-breast malignancy (excluding in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to enrollment in this study Bilateral invasive or in-situ breast cancer Inflammatory breast cancer Clinical or radiological evidence of distant metastases by computed tomography (CT), chest X-ray, abdominal/thoracic ultrasound, bone scan, and/or liver function tests including total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP), within ranges defined in for Part B of the study Prior hormone therapy, chemotherapy, biologic, targeted therapies, or radiation therapy for this malignancy. Prior bisphosphonate therapy is allowed Pregnant and lactating women: Effects on a developing human fetus of chemotherapeutic agents at the recommended therapeutic dose remain incompletely defined. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to study entry and for the duration of study treatment phase. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapeutic agents, women who are breastfeeding will be excluded. If a participant is of child-bearing potential (women are not considered of childbearing potential if they are at least 2 years postmenopausal and/or surgically sterile), she must have documented negative serum or negative urine pregnancy tests within 14 days of entry to the study (i.e., within 14 days of signing the informed consent document) Subjects with psychiatric illness and/or other specific situations that would limit compliance with study requirements and compromise participant follow-up Lack of ability to understand and willingness to sign a written informed consent document. Note: Subjects who were enrolled prior to this amendment will be considered eligible even if the HIV/Hep C and pregnancy test were not preformed due to each country standards. FOR PART B OF THE STUDY: Participants, who successfully enrolled into the first part of the study and who, according to local institutional guidelines, are candidates for neoadjuvant chemotherapy will participate in Part B of the study. Participants must also meet the and described below Histologically confirmed new primary adenocarcinoma of the breast AJCC 7 clinical stage II or III. All histological types are included Hormone status: Any tumor ER/PgR status, any HER2/neu status as measured by local hospital pathology laboratory following US LA CRN standard operating procedures (SOPs)