Trial Information

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

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.