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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2001

Primary Completion Date

June 30, 2003

Study Completion Date

June 30, 2003

Conditions
Carcinoma, Metastatic Breast
Interventions
DRUG

CPG 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.

DRUG

Herceptin®

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

DRUG

CPG 7909

Each 0.04 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.

DRUG

Herceptin®

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

DRUG

CPG 7909

Each 0.16 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.

DRUG

Herceptin®

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

DRUG

CPG 7909

Each 0.32 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.

DRUG

Herceptin®

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

Trial Locations (8)

15213

Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp., Pittsburgh

21201

Greenebaum Cancer Center at Univ. of Maryland, Baltimore

33324

Cancer Research Network, Inc., Plantation

48109

Comprehensive Cancer Center, University of Michigan, Ann Arbor

06030

Univ. of Connecticut Health Center, Farmington

02115

Dana-Farber Cancer Institute, Boston

07039

Cancer Center at Saint Barnabas Medical Center, Livingston

05401

Fletcher Allen Health Care, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00031278 - Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter