Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
This phase II is studying the side effects and how well carboplatin and paclitaxel
 albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab
 before surgery works in treating patients with stage I-III breast cancer. Drugs used in
 chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation,
 work in different ways to stop the growth of tumor cells, either by killing the cells or by
 stopping them from dividing. Monoclonal antibodies, such as bevacizumab and trastuzumab, can
 block tumor growth in different ways. Some block the ability of tumor cells to grow and
 spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
 Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together
 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs
 to be removed.
PRIMARY OBJECTIVES:

 I. To estimate 2 year progression-free survival in patients with breast cancer more than 1 cm
 and/or lymph node positive breast cancer treated with weekly Carboplatin/Nab-Paclitaxel (with
 trastuzumab in patients with HER2+ disease, and with bevacizumab in HER2-).

 II. To measure clinical response rates in patients treated in the neoadjuvant setting.

 III. To measure the microscopic pathological response rate of this regimen in patients
 treated in the neoadjuvant setting.

 IV. To measure the toxicity and delivered dose intensity of this regimen. V. To assess the
 association between microscopic pathologic complete response and clinical complete response
 at the primary tumor site in these patients.

 VI. To measure the outcome of patients treated with doxorubicin and cyclophosphamide with
 patients not treated with doxorubicin and cyclophosphamide.

 SECONDARY OBJECTIVES:

 I. Develop quantitative analysis methods to obtain pre-treatment tumor characteristic
 morphological, enhancement kinetic, and Choline metabolic parameters in breast cancer. Select
 an optimal set of features using the logistic regression analysis and the Artificial Neural
 Network (ANN) to predict pathologic complete remission (pCR) in HER-2 positive and negative
 arm.

 II. Investigate whether the early response patterns, analyzed using the percent tumor size
 changes, or changes in other lesion characteristic parameters, can be used to predict
 pathologic complete remission (pCR) in HER-2 positive and negative arm.

 III. Investigate whether combining the pre-treatment tumor characteristic parameters, and the
 early response pattern during the treatment course, can achieve a higher "area under the
 receiver operating characteristic (ROC) curve" (AUC) in prediction of pCR than those based on
 pre-treatment MRI characteristics or tumor response patterns alone.

 OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
 minutes and carboplatin IV over 60 minutes once weekly for 12 weeks. Patients with
 HER2-positive disease receive trastuzumab IV over 30-90 minutes once weekly for 12 weeks and
 patients with HER2-negative disease receive bevacizumab IV over 30-90 minutes once every two
 weeks for 5 doses. Treatment continues in the absence of disease progression or unacceptable
 toxicity. Beginning 21-40 days later, patients undergo surgery.

 After completion of study treatment, patients are followed for 5 years.
-  Patients must be women with a histologically confirmed diagnosis of breast cancer that
 is more than 1 cm and or lymph node positive

 -  Physical examination, and scans needed for tumor assessment must be performed within
 90 days prior to registration

 -  Patients with the clinical diagnosis of congestive heart failure or angina pectoris
 are NOT eligible

 -  Serum creatinine within normal limits within 90 days prior to registration

 -  Bilirubin within normal limits within 90 days prior to registration

 -  Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate
 transaminase (SGPT) =< 2 x the institutional upper limit of normal within 90 days
 prior to registration

 -  Absolute neutrophil count (ANC) of >= 1,500/microliters within 90 days prior to
 registration

 -  Platelet count of >= 100,000/microliters within 90 days prior to registration

 -  Patients must have a performance status of 0-2 by Zubrod criteria

 -  Pregnant or nursing women may not participate; women of reproductive potential may not
 participate unless they have agreed to use an effective contraceptive method;
 pregnancy test required for women of childbearing potential

 -  In calculating days of tests and measurements, the day a test or measurement is done
 is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks
 later would be considered day 28; this allows for efficient patient scheduling without
 exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may
 be extended to the next working day

 -  All patients must be informed of the investigational nature of this study and must
 sign and give written informed consent in accordance with institutional and federal
 guidelines