CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Carcinoma, Breast
• Interventions: Drug: 0.08 mg/kg CpG 7909; Drug: 0.04 mg/kg CpG 7909; Drug: 0.12 mg/kg CpG 7909; Drug: 0.16 mg/kg CpG 7909; Drug: Herceptin®

• Registration Number: NCT00043394
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-08-08
• Study First Submitted QC: 2002-08-09
• Study First Posted: 2002-08-12
• Study Start: 2002-09
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-11
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 4	Herceptin®	0.16 mg/kg CpG 7909
Cohort 1	Herceptin®	0.04 mg/kg CpG 7909
Cohort 2	0.08 mg/kg CpG 7909	0.08 mg/kg CpG 7909
Cohort 1	0.04 mg/kg CpG 7909	0.04 mg/kg CpG 7909
Cohort 2	Herceptin®	0.08 mg/kg CpG 7909
Cohort 3	0.12 mg/kg CpG 7909	0.12 mg/kg CpG 7909 Injection once weekly
Cohort 3	Herceptin®	0.12 mg/kg CpG 7909 Injection once weekly
Cohort 4	0.16 mg/kg CpG 7909	0.16 mg/kg CpG 7909

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Burlington, Vermont, United States