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

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Metastatic Breast

Treatments: Drug: Herceptin®; Drug: CPG 7909

Study type: Interventional

Funder types: Industry

Identifiers

NCT00031278

A8501020

C005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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%.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Cohort 1

Experimental group

Description:

0.01 mg/kg CPG 7909 plus Herceptin®

Treatment:

Drug: CPG 7909

Drug: Herceptin®

Drug: CPG 7909

Drug: Herceptin®

Drug: Herceptin®

Drug: CPG 7909

Drug: CPG 7909

Drug: Herceptin®

Cohort 2

Experimental group

Description:

0.04 mg/kg CPG 7909 plus Herceptin®

Treatment:

Drug: CPG 7909

Drug: Herceptin®

Drug: CPG 7909

Drug: Herceptin®

Drug: Herceptin®

Drug: CPG 7909

Drug: CPG 7909

Drug: Herceptin®

Cohort 3

Experimental group

Description:

0.16 mg/kg CPG 7909 plus Herceptin®

Treatment:

Drug: CPG 7909

Drug: Herceptin®

Drug: CPG 7909

Drug: Herceptin®

Drug: Herceptin®

Drug: CPG 7909

Drug: CPG 7909

Drug: Herceptin®

Cohort 4

Experimental group

Description:

0.32 mg/kg CPG 7909 plus Herceptin®

Treatment:

Drug: CPG 7909

Drug: Herceptin®

Drug: CPG 7909

Drug: Herceptin®

Drug: Herceptin®

Drug: CPG 7909

Drug: CPG 7909

Drug: Herceptin®