A Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.

Key

Inclusion Criteria:

1. Males and females at least 18 years of age

2. Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC
chemotherapy as based on investigator judgment

3. Candidates for TAC chemotherapy, and no prior treatment with anthracyclines

Key Exclusion Criteria:

1. Received chemotherapy within last 3 month prior to screening, or expected to receive
any chemotherapy other than TAC and / or immunotherapy between screening and 30 days
after last planned study drug administration

2. Any clinically significant findings on history or examination that, in the opinion of
the investigator, would preclude administration of TAC chemotherapy in the full dose,
including abnormal liver function, inadequate cardiac function or clinically
significant cardiac disease, neuropathy or other disease

3. Prior bone marrow or peripheral blood hematopoietic stem cell transplant

4. Any active cancer or history of prior malignancy within the last 5 years except
carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of
the skin or any surgically cured malignancy diagnosed 5 years or more before
diagnosis of breast cancer