CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

Official Title
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A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Conditions
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Carcinoma, Breast

Intervention / Treatment
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* Drug: 0.04 mg/kg CpG 7909
* Drug: Herceptin®
* Drug: 0.08 mg/kg CpG 7909
* Drug: Herceptin®
* Drug: 0.12 mg/kg CpG 7909
* Drug: Herceptin®
* Drug: 0.16 mg/kg CpG 7909
* Drug: Herceptin®


Participation Criteria
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Eligibility Criteria
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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 may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy. Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan Exclusion Criteria: Any prior therapy with anthracycline + Herceptin® concurrently 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% Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>0.04 mg/kg CpG 7909 | Drug: 0.04 mg/kg CpG 7909<br>* 0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks<br>* Other names: PF-03512676, ProMune;Drug: Herceptin®<br>* Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.<br>* Other names: Trastuzumab;|
| Experimental: Cohort 2<br>0.08 mg/kg CpG 7909 | Drug: 0.08 mg/kg CpG 7909<br>* 0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks<br>* Other names: PF-03512676, ProMune;Drug: Herceptin®<br>* Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.<br>* Other names: Trastuzumab;|
| Experimental: Cohort 3<br>0.12 mg/kg CpG 7909 Injection once weekly | Drug: 0.12 mg/kg CpG 7909<br>* 0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks<br>* Other names: PF-03512676, ProMune;Drug: Herceptin®<br>* Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.<br>* Other names: Trastuzumab;|
| Experimental: Cohort 4<br>0.16 mg/kg CpG 7909 | Drug: 0.16 mg/kg CpG 7909<br>* 0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks<br>* Other names: PF-03512676, ProMune;Drug: Herceptin®<br>* Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.<br>* Other names: Trastuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin® |  | 24 weeks | 
| Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time. |  | 24 weeks | 
| Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time. |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.