Clinical trial NCT00824733 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: trastuzumab, pf03512676
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    inaccurate patient accrual for trial
  
Eligibility criteria:

        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