Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer
- Compare the overall response rate in women with estrogen receptor-negative,
progesterone receptor-negative, HER2-nonoverexpressing metastatic breast cancer treated
with cetuximab with vs without carboplatin.
- Compare the time to disease progression in patients treated with these regimens.
- Correlate downstream effects of EGFR inhibitor on MAPK, AKT, Ki67, and EGFR-dependent
signaling, proliferation, and apoptosis with toxicity and response in patients with
accessible tumors treated with these regimens.
- Determine the changes in biomarkers and gene expression in circulating tumor cells
- Compare the overall survival rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive cetuximab IV over 60-120 minutes once a week.
- Arm II: Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15.
In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm
Blood samples are collected periodically throughout study for correlative biomarker analysis
by IHC and gene expression analysis.
After completion of study treatment, patients are followed every 4 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Overall disease response rate
Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radigographic response using RECIST criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).
every 8 weeks
Lisa A. Carey, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Washington Cancer Institute at Washington Hospital Center||Washington, District of Columbia 20010|
|Baylor University Medical Center - Houston||Houston, Texas 77030-2399|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham||Birmingham, Alabama 35294|
|Rex Cancer Center at Rex Hospital||Raleigh, North Carolina 27607|