A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease
I. To determine the response rate to the combination of carboplatin, paclitaxel and
panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer.
I. To determine the tolerability and toxicities of the combination of paclitaxel,
carboplatin and panitumumab.
II. To determine the markers that co-occur with EGFR expression in the triple negative
III. To assess the association between tumor biomarkers and clinical outcomes (response and
IV. To examine the effect this regimen has on time to progression and survival.
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also
receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in
the absence of disease progression or unacceptable toxicity.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor activity as assessed by objective tumor response according to RECIST criteria
Wake Forest University
United States: Institutional Review Board
|Ochsner Clinic Foundation||New Orleans, Louisiana 70121|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|