Carcinoma, Metastatic Breast
Conditions
Keywords
Metastatic, Breast, Cancer, immunotherapy, CPG 7909
Brief summary
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
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Interventions
DRUGCPG 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.
DRUGHerceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
United States
Outcome results
None listed