UAB 0543 - PHASE 2 TRIAL OF C225 -/+ CARBOPLATIN IN TRIPLE NEGATIVE METASTATIC

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objectives of this study are to: 1) assess overall response rate to single agent cetuximab in triple negative breast cancer and 2) assess overall response rate to combination cetuximab plus carboplatin in triple negative metastatic breast cancers. The study will enroll about 100 women with estrogen receptor (ER) and progesterone receptor (PR) and HER-2 negative metastatic breast cancer to get 93 that will be randomized. Women will be enrolled at several collaborating centers over a two-year period. Participants may have received no more than three prior chemotherapy regimens for adjuvant or metastatic disease, but no prior platinum-containing regimens for metastatic disease or EGFR inhibitors with therapeutic intent. Participants will initially be randomized to receive weekly Cetuximab or weekly cetuximab plus carboplatin (three of four weeks). They will be restaged for evaluation of measurable disease every 8 weeks, and tumor response defined by RECIST criteria. Upon progression on Arm 1, those participants will remain on cetuximab but carboplatin will be added to the regimen. For participants with accessible tumor, biopsies will be performed after one weekly of cetuximab and after one week of combination therapy.