Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Cetuximab; Ixabepilone
Intervention description: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.; Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients
      with metastatic breast cancer after failing other treatments. Cetuximab is active against
      tumors expressing epidermal growth factor receptor w/demonstrated activity in head & neck and
      colorectal tumors and may be effective in some breast cancers known to express EGFR. Study
      seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor
      therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologic confirmation of invasive breast carcinoma.

          -  Patients must have intact primary tumor.

          -  Patients greater than or equal to 18 years.

          -  Patients should have T1N1-3M0 or T2-4 N0-3M0.

          -  Patients with bilateral breast cancer are eligible.

          -  Patients with second primary breast cancers are eligible.

          -  Patients should have a Karnofsky performance scale of greater than or equal to 70%.

          -  Patients must have clinically measurable disease to be treated in the neoadjuvant
             setting.

          -  Patients should have adequate bone marrow function, as defined by peripheral
             granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater
             than or equal to 100000mm^3.

          -  Patients must have adequate liver function with a bilirubin within normal laboratory
             values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper
             limit of normal (ULN) of the institution.

          -  Patients should have adequate renal function with creatinine levels within normal
             range.

          -  Patients should have a normal left ventricular ejection fraction (LVEF) of greater
             than or equal to 50%.

          -  Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).

          -  WOCBP must use a reliable and appropriate contraceptive method during the study and
             six months after chemotherapy is completed. WOCBP are women who are not menopausal for
             12 months or had no previous surgical sterilization.

          -  Patients must agree to have study biopsies.

          -  Patients must sign an informed consent indicating that they are aware of the
             investigational nature of the study, in keeping with institutional policy.

        Exclusion Criteria:

          -  Patients with a history of other invasive malignancies diagnosed and treated within
             the previous 5 years, except non-melanoma skin cancer and non-invasive cervical
             cancer.

          -  Her2Neu, ER and PR positive patients should be excluded.

          -  Patients with Inflammatory breast cancer (IBC) are excluded.

          -  Patients with an organ allograft or other history of immune compromise.

          -  Prior treatment with any investigational drug within the preceding 4 weeks.

          -  Chronic treatment with systemic steroids or another immunosuppressive agent.

          -  A Known history of HIV seropositivity.

          -  Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
             (except low dose coumarin defined as 1 mg a day).

          -  Other concurrent and/or uncontrolled medical disease which could compromise
             participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension,
             severe infection, severe malnutrition, unstable angina, or congestive heart failure -
             New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic
             heart disease, myocardial infarction within six months, chronic liver or renal
             disease, active upper GI tract ulceration).

          -  Patients with a pre-existing peripheral neuropathy.