Patient Exclusion Criteria

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  • Patients will be disqualified from study participation based on the following exclusion criteria:
  • Patients for whom potentially curative antineoplastic therapy is available
  • Patients who previously received paclitaxel or other taxane treatment in the frontline or locally advanced setting
  • Patients who are pregnant or lactating
  • Patients with an active infection or with an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled)
  • Patients with known brain metastasis
  • Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies
  • Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL, unless a patient has been de-sensitized in accordance with institutional guidelines
  • Patients with a known history of hypersensitivity to trastuzumab or any of its components (for group 1 only)
  • Patients who have received other recent anti-tumor therapy. This includes the following:
    • Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111
      • Dosing within <28 days since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed
      • Patients in the Traditional HER2 group already receiving trastuzumab do not require a wash-out period from trastuzumab (for group 1 only)
    • Any standard chemotherapy or radiation or other therapy within 14 days prior to the first scheduled dose of MM-111
    • Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other antineoplastic therapies.  Patients with a known peripheral neuropathy must present with a grade 1 severity or less according to NCI CTCAE 4.0
  • Patients with active or prior history of New York Heart Association (NYHA) congestive heart failure or left ventricular ejection fraction (LVEF) <50%
  • History of myocardial infarction within 12 months of enrollment
  • Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg)
  • Known angina pectoris requiring medication
  • Known clinically significant heart valve disease
  • Known history of high-risk arrhythmias requiring medical attention (chronic stable well controlled atrial fibrillation is permissible)
  • Active gastrointestinal bleeding
  • Patients who have received prior maximum cumulative anthracycline doses:
    • Doxorubicin or liposomal doxorubicin doses >360 mg/m2
    • Mitoxantrone >120 mg/m2 and idarubicin >90 mg/m2
    • Epirubicin doses higher than 720 mg/m2
    • Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin)
    • If more than 1 anthracycline has been used, the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin
  • Patients with known human immunodeficiency virus (HIV). Patients with Hepatitis B surface antigen (carriers) may be enrolled but must receive nucleoside/nucleotide analogue or other suitable treatment for Hepatitis B per institutional guidelines
  • Patients with any other medical or psychological condition, deemed by the investigator to likely interfere with a patient’s ability to sign informed consent or cooperate and participate in the study, or interfere with the interpretation of the study results

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