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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 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Carcinoma, Metastatic Breast

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Trial Information

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.

Inclusion 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%.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Harold Burstein, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

C005

NCT ID:

NCT00031278

Start Date:

October 2001

Completion Date:

June 2003

Related Keywords:

  • Carcinoma, Metastatic Breast
  • Metastatic
  • Breast
  • Cancer
  • immunotherapy
  • CPG 7909
  • Breast Neoplasms
  • Carcinoma

Name

Location
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