The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2
Objective Response Rates (ORR)
To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: 2 years
Duration of Response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.
Median Time of Progression-free Survival (PFS)
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time frame: 2 years
Median Overall Survival (OS)
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Asscociates
Phoenix, Arizona, United States
Northern AZ Hematology & Oncology Assoc
Sedona, Arizona, United States
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States
Northwestern Connecticut Oncology Hematology Associates
Torrington, Connecticut, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Hematology Oncology Associates of IL
Chicago, Illinois, United States
...and 49 more locations