Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: nab paclitaxel; Cyclophosphamide; Trastuzumab
Intervention description: 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle); 600 mg/m2 of IV cyclophosphamide; 8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Stage Breast Cancer; Her2-positive; nab paclitaxel; cyclophosphamide; trastuzumab

Summary:

      This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study;
      however, progression-free survival will be followed and determined for the patients in this
      study. Approximately 50 patients are planned to be enrolled in this study.
    

Eligibility criteria:

        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.