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
Phase II part of study not initiated because the development plan modified the route of
administration to subcutaneous injection.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Harold Burstein, M.D., Ph.D.
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Fletcher Allen Health Care||Burlington, Vermont 05401|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Cancer Research Network, Inc.||Plantation, Florida 33324|
|Univ. of Connecticut Health Center||Farmington, Connecticut 06030|
|Greenebaum Cancer Center at Univ. of Maryland||Baltimore, Maryland 21201|
|Comprehensive Cancer Center, University of Michigan||Ann Arbor, Michigan 48109|
|Cancer Center at Saint Barnabas Medical Center||Livingston, New Jersey 07039|
|Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.||Pittsburgh, Pennsylvania 15213|