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

Study Overview
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Brief Summary
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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.

Detailed Description
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Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Official Title
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A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer

Conditions
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Carcinoma, Metastatic Breast

Intervention / Treatment
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* Drug: CPG 7909
* Drug: Herceptin®
* Drug: CPG 7909
* Drug: Herceptin®
* Drug: CPG 7909
* Drug: Herceptin®
* Drug: CPG 7909
* Drug: Herceptin®


Participation Criteria
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Eligibility Criteria
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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%.

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>0.01 mg/kg CPG 7909 plus Herceptin® | Drug: CPG 7909<br>* 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.<br>* Other names: PF-3512676, ProMune;Drug: Herceptin®<br>* Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert<br>* Other names: trastuzumab;|
| Experimental: Cohort 2<br>0.04 mg/kg CPG 7909 plus Herceptin® | Drug: CPG 7909<br>* 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.<br>* Other names: PF-3512676, ProMune;Drug: Herceptin®<br>* Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert<br>* Other names: trastuzumab;|
| Experimental: Cohort 3<br>0.16 mg/kg CPG 7909 plus Herceptin® | Drug: CPG 7909<br>* 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.<br>* Other names: PF-3512676, ProMune;Drug: Herceptin®<br>* Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert<br>* Other names: trastuzumab;|
| Experimental: Cohort 4<br>0.32 mg/kg CPG 7909 plus Herceptin® | Drug: CPG 7909<br>* 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.<br>* Other names: PF-3512676, ProMune;Drug: Herceptin®<br>* Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert<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, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer |  |  | 
| Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time |  |  | 
| Phase II: To evaluate duration of response, time to disease progression, and survival time |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic, Breast, Cancer, immunotherapy, CPG 7909