Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

• Drug: CPG 7909
  
  Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
  Other Name: PF-3512676, ProMune
• Drug: Herceptin®
  
  Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
  Other Name: trastuzumab
• Drug: CPG 7909
  
  Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
  Other Name: PF-3512676, ProMune
• Drug: CPG 7909
  
  Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
  Other Name: PF-3512676, ProMune
• Drug: CPG 7909
  
  Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
  Other Name: PF-3512676, ProMune

• Experimental: Cohort 1
  
  0.01 mg/kg CPG 7909 plus Herceptin®
  Interventions:
  

  • Drug: CPG 7909
  • Drug: Herceptin®
• Experimental: Cohort 2
  
  0.04 mg/kg CPG 7909 plus Herceptin®
  Interventions:
  

  • Drug: CPG 7909
  • Drug: Herceptin®
• Experimental: Cohort 3
  
  0.16 mg/kg CPG 7909 plus Herceptin®
  Interventions:
  

  • Drug: CPG 7909
  • Drug: Herceptin®
• Experimental: Cohort 4
  
  0.32 mg/kg CPG 7909 plus Herceptin®
  Interventions:
  

  • Drug: CPG 7909
  • Drug: Herceptin®

INCLUSION CRITERIA Inclusion Criteria

• Histologically confirmed breast cancer with metastases.
• Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry.
• Patients must be candidates for single agent Herceptin treatment according to the Herceptin® label.

Exclusion Criteria

• Any prior therapy with anthracycline + Herceptin®.
• Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%.