Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

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.