Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer
• * Locally advanced or metastatic disease
• HER2-overexpressing tumor, defined as 3+ overexpression by IHC and/or HER2 amplified by FISH
• Non-measurable disease allowed
• Achieved partial response, complete response, or stable disease (i.e., no disease progression for ≥ 12 weeks) while on trastuzumab (Herceptin®) and chemotherapy, hormonal therapy alone, or trastuzumab alone
• * Last dose of trastuzumab must have been administered within the past 16 weeks
• No unstable brain metastases
• * Patients with brain metastases are eligible provided they have been stable for ≥ 1 month after surgery or radiotherapy/radiosurgery AND off corticosteroids and anticonvulsants for ≥ 4 weeks
• Hormone receptor status unspecified
• PATIENT CHARACTERISTICS:
• ECOG(Eastern Cooperative Oncology Group)performance status (PS) 0-2 (Karnofsky PS 70-100%)
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin \> 8 g/dL (transfusion/epoetin alfa allowed)
• Platelet count ≥ 100,000/mm³
• Total bilirubin \< 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if known liver metastases)
• Creatinine \< 2 mg/mL
• Ejection fraction ≥ 50% by echocardiogram or MUGA
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study treatment
• No ongoing or active infection requiring oral or IV antibiotics
• No known autoimmune disorders or antibody-mediated disorders
• No known HIV positivity
• No known history of hepatitis B or C (active and/or previously treated)
• No other malignancies within the past 5 years except nonmelanoma skin cancer or cervical cancer in situ
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 12 weeks since prior chloroquine
• More than 4 weeks since prior growth factors
• More than 4 weeks since prior systemic corticosteroids
• More than 4 weeks since prior chemotherapy, radiotherapy, or monoclonal antibody therapy (except trastuzumab)
• No prior agatolimod sodium
• No prior allogeneic stem cell transplantation
• No prior continuous treatment with single-agent trastuzumab for \> 6 months
• No more than 3 prior chemotherapy regimens for metastatic breast cancer
• Any number of prior hormonal therapies allowed
• No other concurrent investigational agents or monoclonal antibodies
• No other concurrent anticancer agents or therapies
• Concurrent bisphosphonates for skeletal metastasis allowed