Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab; carboplatin; nab-paclitaxel; Surgery; Adjuvant chemotherapy
Intervention description: bevacizumab 10 mg/kg on days 1 and 15 administered every 28 days [1 cycle] for 5 cycles; AUC 2 IV on days 1, 8, and 15; 100 mg/M2 IV; lumpectomy or mastectomy along with axillary lymph node dissection approximately 4-5 weeks after completion of NCT.; All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab at 15 mg/kg IV every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation and carboplatin, 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, can block tumor growth in different ways. Some find tumor cells and help kill
      them or carry tumor-killing substances to them. Others interfere with the ability of tumor
      cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking
      blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel
      albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works
      in treating women undergoing surgery for stage II or stage III breast cancer.
    

Eligibility criteria:

        Inclusion:

          -  Histologically confirmed breast cancer

          -  Clinically or radiographically measurable residual tumor after core biopsy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Age ≥18 yrs

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 100,000/ mm³

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Urine protein:creatinine ratio < 1.0

          -  AST (aspartate aminotransferase) and ALT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Bilirubin normal

          -  Women of childbearing potential must use effective contraception

          -  Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA

        Exclusion:

          -  No residual tumor after initial biopsy

          -  Peripheral neuropathy of grade 2 or higher

          -  HER-2 neu overexpression either by IHC 3+ or FISH+

          -  No history of any prior treatment of breast cancer.

          -  No history of unstable angina or myocardial infarction within the past 12 months

          -  Pregnant or nursing women

          -  Anticoagulation therapy within the last 6 months

          -  History of gastrointestinal bleeding

          -  Recent hemoptysis

          -  No known hepatitis B or HIV seropositivity

          -  No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150
             mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association class II-IV congestive heart failure

          -  History of stroke or transient ischemic attack at any time

          -  Significant vascular disease (e.g., aortic aneurysm or aortic dissection)

          -  No symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Significant traumatic injury within the past 28 days

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within the past 6 months

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Known hypersensitivity to any component of bevacizumab