Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)

Inclusion Criteria:

- Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast
cancer, with an interval between definitive breast surgery and study registration of
<60 days.

- Definitive surgical treatment must be either mastectomy or breast-conserving therapy
with axillary lymph node dissection for operable breast cancer (pT1 4 [including
inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from
definitive surgery must be histologically free of invasive adenocarcinoma and ductal
carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive
margin.

- Patients with ≥1 axillary lymph node containing metastatic adenocarcinoma measuring
>0.2 mm, OR lymph node-negative patients with high-risk features

- Patients with HER2/neu positive or negative tumors (HER2 positivity must be
documented by FISH positivity or IHC 3+).

- Patients who are to receive trastuzumab must have normal cardiac function (MUGA
[cardiac ejection fraction >50%, or greater than or equal to the institutional lower
limit of normal], or echocardiogram [ECHO] within institutional normal limits).

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.

- Patients who are either chemotherapy naïve, or who have received prior chemotherapy
>5 years ago.

- Patients with previous invasive cancers (including breast cancer) eligible only if
treated >5 years prior to entering this study, and show no evidence of recurrent
disease.

- Adequate bone marrow function

- Adequate liver function,

- Adequate renal function,

- Patients of childbearing potential must use an effective method of contraception that
is acceptable to their study physician from the time of signing informed consent
until at least 3 months after the last dose of protocol treatment, and must have a
negative pre study serum pregnancy test.

- Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
criteria.

- MammoSite® brachytherapy radiation accepted when performed immediately following
surgery and prior to receiving chemotherapy.

- Patients with bilateral, synchronous breast cancer, provided that one primary tumor
meets the inclusion criteria.

Exclusion Criteria:

- Patients who are pregnant or breastfeeding.

- M1 metastatic disease.

- Patients requiring neoadjuvant chemotherapy.

- Life expectancy of greater than 6 months.

- History of cardiac disease, with a New York Heart Association (NYHA) Class II or
greater CHF

- Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of
treatment, serious arrhythmias requiring medication for treatment, any history of
stroke or transient ischemic attack at any time, clinically significant peripheral
vascular disease, or evidence of a bleeding diathesis or coagulopathy.

- Any investigational agent within 30 days of receiving the first dose of study drug.

- Treatment with prior trastuzumab or bevacizumab therapy.

- Concurrent treatment with any other anti-cancer therapy is not permitted.

- History of significant psychiatric disorders.

- History of active, uncontrolled infection.

- A serious, non-healing wound, ulcer, or bone fracture.

- Any other diseases, metabolic dysfunction, findings from a physical examination, or
clinical laboratory test results that give reasonable suspicion of a disease or
condition that contraindicates the use of an investigational drug, that may affect
the interpretation of the results or that renders the patient at high risk from
treatment complications.