MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

Exclusion Criteria

• •Patients who are pregnant or lactating
• •Patients with an active infection or with an unexplained fever \> 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing.
• •Patients with untreated and/or symptomatic metastatic CNS malignancies.
• •Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.
• •Patients who have received other recent antitumor therapy including:
• •* Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111
• •* Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 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.)
• •* Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111
• •Patients who have previously received MM-111
• •Patients with NYHA Class III or IV congestive heart failure or LVEF \< 50%
• •Patients with a history of allogeneic transplant
• •Patients with known HIV, hepatitis B or C (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial)
• •Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results