CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Breast

In brief

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

Key facts

Study ID

NCT00043394

Run by

Pfizer

People needed

16

Starts

2002-09-01

Expected to finish

2003-10-01

Last updated by the study team

2009-03-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Berkely, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Palm Springs, California, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Plantation, Florida, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Dearborn, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — West Bloomfield, Michigan, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.