Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
Condition: Breast Cancer; HER2-negative Breast Cancer; HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Carboplatin; paclitaxel albumin-stabilized nanoparticle formulation; bevacizumab; trastuzumab; magnetic resonance imaging; therapeutic conventional surgery
Intervention description: Given IV; Given IV; Given IV; Given IV; Optional correlative studies; Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Trastuzumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: Female
Minimum age: 21 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: pre-operative; neo-adjuvant; triple negative; HER2 positive; hormone receptor positive; breast; Carboplatin; Nab-paclitaxel; Trastuzumab; Bevacizumab; Inflammatory

Summary:

      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.
    

Eligibility criteria:

        -  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