Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer

Inclusion Criteria

• •The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
• •Women \>/= 18 years of age.
• •Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of \< 60 days. (Note: Cycle 1 of chemotherapy treatment may NOT be infused until \> 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)
• •Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 \[including inflammatory\], pNO-3, and MO). 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.
• •Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.
• •High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0\[sn\]) OR negative lymph node dissection (pN0) disease AND tumor size \> 2 cm or tumor size \>/= 1 cm with at least one of the following factors:
• •* negative estrogen receptor (ER) and negative progesterone receptor (PR) status
• •* histologic and/or nuclear Grade 2-3; or
• •* age \< 35 years
• •HER2/neu positive or negative tumors are eligible. HER2 positivity must be documented by fluorescence in situ hybridization (FISH).
• •Estrogen and progesterone receptor status must be performed on the primary tumor prior to study entry. Results must be pending or known at the time of study entry.
• •Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) or shortening fraction (multiple-gated acquisition \[MUGA\] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.
• •Hematology evaluation within 2 weeks prior to study entry:
• •* Absolute neutrophil count (ANC) \>/= 1,500/μL
• •* Platelets \>/= 100,000/μL
• •* Hemoglobin \>/= 9 g/dL
• •Hepatic function evaluation within 2 weeks prior to study entry:
• •* Total bilirubin \</= ULN for the institution
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be in the acceptable range.
• •Complete staging work-up as follows: All subjects must have an appropriate radiographic evaluation, e.g., computed tomography (CT), positron emission tomography (PET)/CT, and/or (magnetic resonance imaging) MRI of the brain, chest, abdomen and pelvis, and imaging of bone by either a bone scan or PET scan. In cases of positive bone imaging, a bone X-ray or MRI evaluation is mandatory to rule out the possibility of metastatic bone scan disease. Other tests may be performed as clinically indicated. It is recommended that all baseline staging should be completed within 35 days prior to study entry.