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

Condition(s) targeted: Carcinoma, Metastatic Breast

Intervention: CPG 7909 (Drug); Herceptin® (Drug); CPG 7909 (Drug); Herceptin® (Drug); CPG 7909 (Drug); Herceptin® (Drug); CPG 7909 (Drug); Herceptin® (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Harold Burstein, M.D., Ph.D., Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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%.

Univ. of Connecticut Health Center, Farmington, Connecticut 06030, United States

Cancer Research Network, Inc., Plantation, Florida 33324, United States

Greenebaum Cancer Center at Univ. of Maryland, Baltimore, Maryland 21201, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Comprehensive Cancer Center, University of Michigan, Ann Arbor, Michigan 48109, United States

Cancer Center at Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States

Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp., Pittsburgh, Pennsylvania 15213, United States

Fletcher Allen Health Care, Burlington, Vermont 05401, United States

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Starting date: October 2001
Last updated: May 26, 2011